Pfizer

CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.

I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.

Asthma exacerbation; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: ek5730), via an unspecified route of administration at the left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history includes adult onset asthma, seasonal allergies, anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included atomoxetine hydrochloride (STRATTERA), vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol and levonorgestrel (SEASONIQUE). The patient experienced asthma exacerbation following vaccination that started 2 hours after (18Dec2020, 3PM) and worsened 1 day later. The pulmonologist advised to nebulize the patient with albuterol due to shortness of breath tightness and clear secretions despite MDI. The patient had to restart controller Symbicort (still with 3x day albuterol on 23Dec2020) and seen at an urgent care. Oral steroids were prescribed (Medrol dose pack). The patient was not hospitalized for the event but the resulted in Emergency room/department or urgent care visit. The event was reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for Flu and COVID (Nasal Swab, PCR) Testing on 23Dec2020 and results were negative. The outcome of the event was recovering.

12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.

About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.

Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2

Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.

Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.

After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.

Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.

Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.

Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic. Oxygen therapy, Methlyprednisolone 125 mg IV push, Diphenhydramine 50 mg IV push.

Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.

Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness

Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.

This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.

0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal

lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered. about 1 hour later had wheezing and chest tightness lasting about 4 hours

Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.

shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years). Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.

Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."

lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.

EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization. The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020. There were no concomitant medications. The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath. The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose. Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks. The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.

15 minutes after receiving the second dose of vaccine, she felt light-headed and short of breath. She received Epinephrine 0.3 mg IM, solumedrol, and Benadryl. She remained hemodynamically stable.

Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.

Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.

Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her PCP and got a steroid shot and took Benadryl on 1/15. On 1/17 she came to the ER with complaints of cough and chest heaviness thought to be caused by the vaccine. She was treated for underlying pneumonia with azithromycin 500mg PO, cefdinir 300mg PO, and a one time dose of methylprednisolone 125mg IM.

During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.

1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small rashes with no itch come and go on eyelid, chin, shoulder.

Within a few minutes I felt like my throat was getting tight, constricted, and maybe even the description would be inflamed. I was still able to breathe okay and swallow with only some restriction so I didnt say anything. I felt a little foggy and shaky as well for about another 2 hours and then was fine.

Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat

Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.

Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.

Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.

Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.

Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020 Improvement with ibuprofen and acetaminophen. Resolved by 1/25/2021

Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of throat "fuzzy", heart rate 140/min for 20 minutes. Her breathing was as if she was "trying to catch my breath" which lasted 5 minutes. At 1pm she experienced fatigue, chills, had fog, and weakness which lasted or approximately 18 hours. She felt much better 48 hours later.

approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also had intermittent itching and chills. Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home

patient developed itching and rash on chest and neck with some throat tightness. RRT called and she was transferred to the ER

My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.

Throat itchy, felt like right side of throat swelling, dizzy, skin hot. Seen by doctor in vaccine clinic who held me for one hour. Took Benadryl which helped reduce throat itching and feeling of swelling in throat.

Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.

Patient reported coughing and shortness of breath 1 hour after Covid vaccine.Pulse Ox 99%, lungs clear, P 88, cough noted. Patient given 25mg oral Benadryl. Coughing subsided

Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.

after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the vaccine, I went to an Express Care they did a Covid 19 test, result was negative, I had a video visit with my doctor because I developed cough, chest tightness and shortness of breath, they did a 2nd Covid 19 test result was negative, The cough become persistent and the cough caused pain in my chest and back, The Doctor prescribed guaifenesin with codeine, albuterol and something for my gums. the cough and pain in chest was worsen and the Doctor gave me the zpack, I was out of work for 10 days. they said I had an acute URI

Patient felt flushed and experienced shortness of breath (history of anxiety, panic attacks). Drank water and felt better in 10 minutes.

Covid 19 vaccination provided by patients work (unknown manufacturer) via phone visit pt reports starting Saturday positive swelling in face, hands and feet, reports improvement in swelling at this time. Positive full body aches, fever, significant fatigue and shortness of breath

Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma. The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.

A few days after the vaccination I begin having mild symptoms as if I had COVID so I went and got tested on 12/24 and was positive for covid. I was experiencing SOB so I had a virtual Urgent Care and was prescribed a weeks worth of Deckadron and antibiotic and all symptoms cleared up. I also experienced extended abdominal distenstion for an extended period of time.

felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.

5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high

red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did

approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and feeling like her throat was "tight" and more difficult to swallow

Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aphasia . Went to sleep, woke up 1 hour later bc I felt like I couldn?t breath. My arms and legs were very heavy felt close to paralyzed. I was able to move but movement was very ataxic and labored. Next morning the limb heaviness was gone, double vision was gone but had blurry vision for approx three days. Still having word finding difficulty, but mild.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium

40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.

Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.

Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.

Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: nothing Face swelling/redness/shortness of breath: Benadryl

lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, solu-medrol 60 mg IV, pepcid 20 mg IV

General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat

Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.

shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.

At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.

Pt stated she currenty has a post nasal drip and she feels like her throat swelling comes and goes. Pt stated she just got very nervous and wanted to be checked out. Pt seen by EMS on site BP: 158/88, P:100, O2:99% on RA. Pt declined to go to hospital. EMS educated pt on signs and symtoms to report and go to the hospital. RN

Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing additional monitoring (30 minutes) after vaccine administration. Patient received vaccine at approximately 11:00am, at which time she left vaccination site to observation site. Approximately 15 miniutes post vaccine administration, patient self-reported feeling of lightheadedness to RN at site. Doctor was informed and called over to assess patient, at which time he diverted patient to the 30 minute observation area and placed on Stryker bed.. During this period, patient continued to feel worsening of pre-syncopal type dizziness and developed parasthesias to bilateral arms and legs. VS at 11:35 am - BP 131/95; HR 82; RR 18; O2 sat 98%. Patient also endorsed some nausea, but did not vomit; negative abdominal pain. Patient did not present with any difficulty breathing, edema, urticaria, pruritis, or globus sensation. VS at 11:50am - BP 115/77; HR 72; RR 18; O2 sat 98%; patient seemed to be relatively comfortable. Clinically ,patient seemed to be improving, parasthesias resolving. Approximately 12:05pm, patient with complaint of increase dizziness, brief episode of chest pain, worsening parasthesias and exihibiting some difficulty breathing. VS at 12:07pm - BP 160/60; HR 90 12:10pm: EpiPen 0.3 mg adminstered to R thigh IM and 911 called. VS post Epi - BP 156/82; HR 151 EMS arrived at 12:15pm EMS started IV but had to wait for transfer due to social situation (2 children with patient). 12:39 pm, patient transported to Medical Center, with children, via EMS. Doctor spoke with ER physician. Patient was discharged at approximately 4:00pm after evaluated by ER physician.

About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100. Fatigued, so went to bed and took ibuprofen. Continued to have significant body aches and rigors. While lying in bed, developed nausea. I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode. I returned to bed bed and still felt very lightheaded and laid down. I had another brief syncopal episode while lying down. I felt short of breath and had chest tightness when I woke up. This was around 11pm. I was evaluated in the ED, where I continued to have body aches and rigors. I developed fever to 101 and was given Advil and Tylenol as well as IVF. Symptoms finally resolved. Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal. Continued to feel significantly fatigued for an additional 48 hours.

Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4 days. Trouble breathing, felt like a weight on my chest and it was difficult to speak lasted for 90 minutes.

Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV. She then refused transport again and departed. 10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%

I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.

heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.

Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.

Throat irritation like it was closing. HR elevated to 120-130. Clear airway with no wheezing, no stridor. Gave 25 mg Benadryl IM but then patient started coughing. Again checked airway, clear with normal lung sounds however with elevated heart rate, persistent coughing, called 911.

summons to vehicle for c/o. " slight throat tightness" She reports is most likely. R/T Anxiety. Resolved with removal of mask, fresh air & emotional support. BP 118/76 - P 55; 16 Resp unablored. Symptom resolved within 3 mins. time.

On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting, headache, dizziness, weakness, fatigue, diarrhea, trouble breathing, rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.

Pfizer bio N Tech covid 19 Started with a slight cough then my throat felt like I couldn't swallow right. Then went to a persistent cough and got hard to swallow chest was tight. Went to the er and was given an epi in and 5 other meds through the iv. Also given a breathing treatment. They diagnosed me with an allergic reaction.

1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - First dose epinephrine administered with patient supply 1:45PM - Second dose epinephrine administered with patient supply 1:50PM - Third dose epinephrine administered with patient supply, EMS arrived, nasal cannula oxygen started 1:55PM - Fourth (PARTIAL... EMS did not remove locking mechanism, not certain how much patient received) dose epinephrine administered with store supply by EMS 2:00PM - Transported by EMS to Emergency Dept.

Patient was brought to hospital. She complained of her throat being itchy and having a cough. In route her throat started to close and they administered Epi and IV Benadryl.

Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.

Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.

03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid

Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram

Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.

lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.

Waves of various symptoms onset about 4 hours post vaccine. Exhaustion, headache, lung pain, achy, hot/cold flashes, arm pain?hot & not able to move it much

Anaphylaxis 40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and anxiety presents to the emergency department from the vaccine clinic with syncope and allergic reaction.She says shortly after getting her COVID-19 vaccine, she felt lightheaded, had near syncope. Per bystanders at the clinic, she had a brief episode of unresponsiveness and then spontaneously returned. She was conversant with multiple members of the code and rapid response team at the bedside. Did initially have some labored breathing but significantly improved. She had no vomiting but had mild nausea also significant improvement. In the field, IV was established and 125 mg of Solu-Medrol was administered. She was also given 1 IM dose of epinephrine. Her symptoms resolved she is at her baseline. Medically stable for discharge. Discharge home with short course of steroid, H2 blocker and Benadryl as needed. Advised patient to follow-up with PCP post discharge. Resume other home medicationS as listed. Of note, the patient had a similar reaction with influenza vaccine.

Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.

Patient received vaccine and within 5 minutes began feeling itchy all over and reported shortness of breath and reported throat was beginning to feel tight. Epi-Pen administered per RN at 1046. BP was 100/62 HR 70 bpm, oxygen saturation 99%. Nasal canula applied at 1048 due to decreasing oxygen saturation. Oxygen saturation promptly returned to 100%. Stat team called and responded, patient taken to ED at 1055 with resolving symptoms, decreased anxiety, and no shortness of breath with an oxygen saturation of 100%.

sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.

pt c/o wheezing, dyspnea, and flushing. She utilized her albuterol inhaler and took benadryl 50mg PO and improved within 10 minutes or so.- pt with hx of asthma, seasonal allergies and eczema

According to the patient, she experienced severe red and hot rash and hive all over her body. She had discomfort breathing and had to go to ER for treatment. She is currently taking loratadine and Benadryl to help treat the rash.

Coughing began about 20 minutes after shot was given. Wheezing began appx 5 minutes later at which point an Epi injection was provided. The Epi injection relieved symptoms. Transportation to ER via ambulance and subsequent monitoring and provided 4x puffs of albuterol inhaler. No further reaction was evident.

Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and EMT Called/Transported to Hospital Emergency Department.

2:33 pt coughing and states SOB. Taken to Triage 2. Pt used albuterol inhaler. Repeated dose as pt did not hold in and exhaled immediately. 2:43 pt states slightly dizzy. Dr. at beside with EMTs. BP 115/63 HR 97, 96% RA 2:51 BP 132/72 HR 85, 98% RA Pt states she is feeling better and ready to leave. Meeting friend. Stable for DC. Pt provided instructions when to return to ER or call 911. pt verbalized understanding and agreed. Pt also told if this becomes annual immunization she needs to notify her MD of previous experiences. Pt agreed.

Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.

At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.

throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.

anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.

Full body aches and pain in both the joints and muscles. Headache, fatigue, easily out of breath. These started the day after and went away the next day. Day after injection saw blood in urine. Has not gone away.

15 minutes after receiving the vaccine, she experienced numbness in her lips (felt 'swollen'). She sat 15 minutes and felt it spread. She talked to the medic, it was still present 30 minutes later. She was noted to have high blood pressure (maybe systolic BP 160-180 mm Hg with elevated HR, does not recall specifics). She was sent to the ED. The numbness over that period spread to the arm and down both legs. She had loss of dexterity in hands (could not peal the aluminum top off an orange juice cup). Mild proximal arm weakness. She was not able to walk. She was numb all over but the right was more affected. She was seen in ED that day 09MAR and later admitted. Later that night had some throat closing/gasping for air sensation. She was monitored clinically, worked with physical and occupational therapy. We chose not to perform a diagnostic LP and just monitored clinically. Work-up detailed below. Discharged hospital on 12MAR. She gradually recovered over several weeks. She was even able to get second dose in series on 3/30/2021 (Pfizer-BioNTech Covid-19 vaccine, lot #: ER 8133, exp 7/2021). She was almost 100% about 3 weeks later. She had a similar return of the numbness and it was in her throat as well, but was immediately controlled by taking diphenhydramine OTC. She was 100% back to normal at our follow-up on 4/27/2021.

general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.

blood clots in left lung which turned into an infarction; blood clots in left lung which turned into an infarction; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration, administered on the left arm on 15Jan2021 (at the age of 40-year-old) at a single dose for COVID-19 immunisation. Medical history included lupus. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had blood clots in left lung which turned into an infarction on 22Feb2021. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 3 days. Therapeutic measures were taken as a result of the events which included blood thinners and anti-inflammatory meds. COVID test post vaccination on 03Mar2021 Nasal Swab: Negative. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely fo rBNT162B2 since there is no plausible mechanism implicating the subject drug to the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort

PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL EFFUSION

difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phone; feels like she is coming down with a respiratory illness; nausea; vomiting; cough; sweating; headache; body pain, achy and uncomfortable; body pain, achy and uncomfortable; overall feeling badly; cognition was not there; Problems with breathing; aspirating; sleepiness; fatigue; stomach pain; her nerve response is strong/affected; swelling in hands and feet; had arm soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm, on 23Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing neuropathy (few years ago, at least since 2015 or 2016), seizures or epilepsy (had focal/absence seizures since a kid; not on any seizure medication, do have a neurologist), hard time with her vision, cancer from an unspecified date to an unspecified date (cancer as a teenager but has been cancer-free for a very long time), and glaucoma. The patient had a family history of cancer and heart problem. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN) taken for glaucoma from Apr2021 and ongoing and gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER8730), intramuscularly in the left arm, on 02Apr2021 for COVID-19 immunisation and experienced not very many side effects with first dose, not enough to be a problem; influenza vaccine (MANUFACTURER UNKNOWN) in 2021 (maybe) for immunisation; and polio vaccine (MANUFACTURER UNKNOWN) as a child for immunisation and experienced severe pain in her legs and she had trouble walking because of pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced difficulty walking and difficulty with speech / slurred speech on 23Apr2021, which required hospitalization from Apr2021 to 26Apr2021. The patient also experienced body pain, achy and uncomfortable, overall feeling badly, cognition was not there, and problems with breathing on 23Apr2021; sweating and headache on 26Apr2021; vomiting and cough on 27Apr2021; feels like she is coming down with a respiratory illness and nausea on 28Apr2021; sleepiness, fatigue, stomach pain, her nerve response is strong/affected, swelling in hands and feet, aspirating, and had arm soreness in Apr2021; and fingers are going numb holding the phone on 29Apr2021. The clinical course was reported as follows: The patient stated that she works in healthcare support and she is a first responder; she identifies as a person with a disability (unspecified). She stated that she did not have very many side effects with first dose, not enough to be a problem. By dinnertime, closer to 18:00-19:00 on 23Apr2021, she started experiencing difficulty walking and with her speech. She was concerned about having a stroke but that she is active and generally healthy. This was unusual for her and she started feeling pain through her body and overall feeling like crap. She did not expect the neurological stuff. By the end of the night on 23Apr2021, she realized she was not feeling good and went to the hospital either that night on 23Apr2021 or early the next day on 24Apr2021 and was admitted to the hospital. The patient stated that her cognition was not there, and her speech was kind of slurry, she felt like everything was slowing, and did not feel like herself. She could not get up unassisted, could not get up out of the bed, chair, or go to bathroom, and still requires the use of a walker and bedside commode, but now with the walker and assistance caller can make it to the bathroom. She also had problems with breathing, but she had a negative COVID-19 PCR test in Apr2021 both arriving to and leaving from the hospital; she did not believe them to be COVID-19 symptoms. At the hospital they did an x-ray or computerized tomography (CT) scan and a magnetic resonance imaging (MRI) on her brain in Apr2021 with unknown results. They gave her 3 or 4 intravenous (IV) unspecified medications and she had her complete blood count (CBC) labs done in Apr2021 with unknown results. There was an issue with her lungs, and she is currently waiting for her doctor to read report to see if there is an issue there. The patient stated that she never experienced anything like this after a vaccine. She cannot even get up and move around it is pretty serious. Caller states that at first when she had the symptoms, she thought she was going to wait it out, maybe her immune system is overresponding, give it a chance to resolve. She reported that she could not stand up, legs were shaking and that she had pain that was from her breasts down; felt like a ton of bricks. The patient stated that she is cognitively alert now, speaking normal. There are times it goes in waves where she feels like she can walk with walker but then a few hours later that is not the case. On Tuesday, 27Apr2021 night, the patient had a light dinner but then she was vomiting. Caller states that the pain was throughout her body and felt like someone lighting firecrackers. The patient initially stated 28Apr2021 was when the cough started, but later clarified she first noticed it on 27Apr2021, but at that time she was vomiting and thought it was due to that. However, the next day 28Apr2021, she still had this cough and that the cough was getting worse. She felt like she has a respiratory issue and has been coughing. She was not able to stay awake, even without taking any medications. She does take medications regularly but did not take the medications those days and not having medications would not cause sleepiness. She thought the doctor gave her sedative, but they did not. She states she had fatigue to the point where she was dead asleep, and nurse would come in to take vitals or do whatever and she would wake up suddenly with someone in front of her. She was sitting up with the nurse trying to read the discharge instructions and she fell asleep sitting up. She also complained of stomach pain. The patient had not been to work and not been having to use her brain and talking like she would for 8+ hours a day. She stated that the cough hurts, it feels like somebody is lighting firecrackers in her body. It also feels like this when she sneezes; the nerve response is strong. She reported that it is not a constant hacking cough, not really a dry cough; the cough is in-between productive and dry cough and cough is a bit better now and worse towards the evening. She still has swelling in her feet and hands. It looks like it has gone down a bit. She has a history of neuropathy and that her fingers are going numb holding the phone now. She got the shot in her left arm and those fingers are going numb. She was so tired and feels like did not get enough sleep. The fatigue had a slight improvement. She is more awake than when she was in the hospital. However, it depends as the day goes on, she is wiped out and has to go lay down. She stated that her nerve response is affected, and she had a difficult time with the neuro exam in Apr2021 with unknown results in the hospital. She was having an issue with her arms. She can't say anything about whether it affected her vision because she already has a hard time with her vision. She stated that she was throwing up pretty bad; the pain was really severe through her whole body while vomiting. After the vomiting stopped, the coughing got worse and she was coughing a little bit before the vomiting, but during the vomiting it was to the point she felt like she was drowning. She reported that she was vomiting through her nose and aspirating. After her MRI she started to get a really bad headache. Then when the nurse was coming to read the discharge information, she started to get sweats. She is not menopausal so she cannot blame the sweating on menopause, as reported. The patient also had arm soreness, but does not care about that long as it does not leave any scars. This was not a big deal for her at all. This started shortly after getting the vaccine. She waited for the observation time and no sensation out of the normal, then later towards the night started feeling like having really bad mensural cramps, like an achy feeling where have to go lie down. Then her lower half started to get worse. Her arms were affected and difficult time with the neuro testing. The patient stated she is now on the road to recovery. The clinical outcome of difficulty walking, difficulty with speech / slurred speech, body pain, achy and uncomfortable, nausea, sleepiness, fatigue, and stomach pain was recovering and of overall feeling badly, cognition was not there, problems with breathing, sweating, headache, vomiting, cough, feels like she is coming down with a respiratory illness, her nerve response is strong/affected, swelling in hands and feet, aspirating, had arm soreness, and fingers are going numb holding the phone was unknown.

Tightening in her throat area; Hard to swallow; Felt tightening in her throat area/hard to swallow/after the second dose it came on later and lasted longer and was more intense; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EB8737; Expiration date was not reported) on the left arm on 09Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). Medical history included shellfish allergy. The patient had no concomitant medications. The patient had previously receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205; Expiration date was not reported) on the left arm on 19Mar2021 (when the patient was 40 years old) for COVID-19 immunization, and had felt tightening in her throat area and hard to swallow. On 09Apr2021, after the second dose of vaccination, the patient also had felt tightening in her throat area and hard to swallow; but it came on later and lasted longer, and was more intense. The events were reported to be serious (medically signficant). The patient had received diphenhydramine (BENADRYL) as treatment for the events. The outcome of the events was recovered on 09Apr2021. Information on lot/batch number was available. Additional information has been requested.

tightening in her throat area; hard to swallow; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at 40 years old) (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation. Medical history included allergy to shellfish from an unknown date. The patient had no concomitant medications. After first shot, patient felt tightening in her throat area for a short period where it was kind of hard to swallow and she took a Benadryl and it went away. The outcome of the events was recovered. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Administered Vaccines. No AE(s) required a visit to Emergency Room or Physician Office. No Prior Vaccinations (within 4 weeks). No AEs following prior vaccinations.

Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative

12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.

Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.

Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.

Patient reported having a swollen epiglottis on the date of the vaccination that did not resolve until the following date.

slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; whole body muscle aches; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (batch/lot number and expiration date not provided, not available/provided to reporter at the time of report completion), via an unspecified route of administration, at arm left, first dose on 23Dec2020 09:15, at single dose, for COVID-19 immunization. No relevant medical history. No known allergies to medications, food, or other products. There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme chills, extreme fatigue and tiredness, whole body muscle aches, slight shortness of breath all lasting over 1 week, all from 23Dec2020 16:15. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (test type: Nasal Swab, test name: rapid test): negative, on both 27Dec2020 and 30Dec2020. The outcome of the events was not recovered. Information about Batch/Lot number has been requested.

Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.

Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction

Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.

Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.

About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.

Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days after vaccine

On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/20, the shortness of breath worsened, developed muscle aches, headache and fatigue continues, blood pressure became elevated. Was seen in the Emergency Room. On 1/11/20 was evaluated by Primary Care Provider. Blood pressure medications were increased and taken off work until stable.

Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.

Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but definitely uncomfortable) over next few hours. Finally tried 2 puffs of my son?s albuterol about 5 hrs post vaccine and felt relief within 20?30 minutes. The next day I had more expected side effects: headache, myalgias, chills and fatigue. No recurrence of the chest symptoms.

2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain

developed a scratchy throat at 2100 and by 2130 felt like throat was tightening. Went to ER and received Benedryl 50 mg IV, Solu medrol IV and protonix IVPB.

severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.

Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days

1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.

Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain

became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home

About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.

~15 minutes post vaccination, reported feeling sensation on right side of throat. Tightness, burning, swollen ("like strep throat, raw") 1515: Dose of 50mg capsule of diphenhydramine PO Can swallow without difficulties Denies troubles breathing 15:25: Notes some improvement in symptoms, denies worsening VS: 148/98

Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.

COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.

tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.

Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)

Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day

Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.

Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.

Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed

22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.

The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".

5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.

Patient reported tightness in throat and swollen glands after injection. Rapid response called. Returned to work with a follow up check by rapid response.

pt c/o tightness feeling in throat. denies SOb. VS taken and stable, pt observed x 30 minutes. vs repeated WNL. Pt d/c home with return precautions. pt states understanding

Pt received COVID vaccine (2nd dose) at 0857. Pt reported after twenty-five minutes that it was "difficult to take a deep breath". RN and EMT took VS. VSS. Clear lung sounds. RN told pt to remain for an additional 15 min of observation. Patient stable and able to leave on her own at the end of 15 min observation.

Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my shirt. Hives went up from my chest to my neck and eventually to my face. About 30 mins after hives started, my breathing became labored. I took 3 Benadryl and was preparing to give my self an EpiPen injection. Benadryl was enough to slowly bring everything back to normal. This began around 6:00 pm, Benadryl was taken around 6:45, by 9:00pm I was completely normal for bed.

Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy. Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.

Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over

Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.

Shortness of breath, difficulty breathing, hard time catching my breath, can?t take a full or deep breath, lightheaded and dizzy

Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.

This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.

heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.

headache runny nose Nausea severe muscle aches fever 102 degrees chills muscle fatigue shortness of breath cough congestion

Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.

Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.

All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite

PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 10ML. PATIENT SENT TO ED.

"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.

It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.

At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone

Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no "acute" (not clarified) current she got but she had got "bulging" (not clarified) disc and "effects" in the past, no "aplasia" (not clarified) nothing, no and she was "marina" (not clarified)." There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was "admitted" (not clarified) she was in the ER being monitored she got "admitted" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included "Throat swelling, tightness, difficulty swallowing." The reporter gave the patient "Api" (not clarified) 0.3 milligram and then also she had "Dimedrol" (not clarified) 125 and then she had CAPCID 20mg IV "piggy back" (not clarified). She had Benadryl 50 milligrams." The outcome of the events was unknown. Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: no) received first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm on 17Jan2021 12:00 at single dose for covid-19 immunization. Medical history included occasional migraines from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), ethinylestradiol, norgestimate (TRI LO MARZIA). The patient experienced lightheadedness, labored breathing on 17Jan2021 12:00, mild body aches on 17Jan2021, nausea, severe headache, vomited all on 18Jan2021 10:00. The event resulted in a visit to emergency room/department or urgent care. Treatment diphenhydramine hydrochloride (BENADRYL) 2mg was introduced. The patient developed lightheadedness within 2 minutes of receiving the COVID 19 vaccination. She did not faint. She was seen and evaluated in the emergency room. She developed labored breathing as well. She developed mild body aches the evening of the vaccine. The morning after the vaccine- around 10 am, She developed nausea, severe headache and vomited once. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies.

Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.

About 10 minutes after receiving COVID vaccine, patient reported that her throat got tight and she became dizzy. Vital signs stable. Patient was administered 12.5mg PO Benadryl and symptoms subsided. Patient was able to be discharged home and asked to contact allergist for further recommendations

Pt. C/O Throat tightening soon after receiving the vaccine, denied difficulty breathing, no impairment of her airway, complaint improved with swallowing water. She also developed an itchy rash (very faint) on left arm. which resolved over about 10 minutes.

Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxis

Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.

A few minutes after taking vaccine i felt my throat tighten like it was closing up and I was very dizzy

1350 Feeling anxious and weird, HX seizures as a child, 1413 Zyrtec given laid down Semi Fowlers position 1444 Report feeling nasal congestion throat swelling has improved. Vitals 124/84, P-79 SPO 97 % Exited and in stable condition.

patient reported swelling of left side of face and we administered Benadryl 25mg at 12:10pm then patients other side of face started swelling. She felt like her throat was closing so we administered 1 dose of EpiPen 0.3mg at 12:30pm and called 911. EMS arrived on site 15 minutes later and took patient to ER.

I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.

Client received her first dose of the Pfizer vaccine. She stated that she was allergic to alcohol and bleach. During her 30minute post-vaccination wait time, she complained of tightness in her chest and attributed it to the smell of alcohol (from the alcohol pads) in the cafeteria. She was evaluated by Nurses, the EMT Personnel working at the POD. She wanted to know if she could use her inhaler, since she was asthmatic. She used her inhaler, stated she felt fine and was observed for another 15 minutes, during which period she denied any symptoms.

Fever, sore throat, swollen lymph nodes in throat, clavicle, armpits and breasts, fatigue, chest tightness, some shortness of breath, rapid heart rate upon moving

heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.

a lot of body aches; headache; some shortness of breath; This is a spontaneous report from a contactable Other Health Professional (HCP) reported for herself. A 41-year-old female patient (pregnant: no) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 18Jan2021 at 12:15 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 41 years old on 28Dec2020 for COVID-19 immunisation (first dose, via intramuscular, administration time=10:00 AM, vaccine location=Left arm). After the second vaccine starting about 10 hours after it was given, the patient had a lot of body aches, headache, and some shortness of breath on 19Jan2021. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No other medications in two weeks. The outcome of the events was recovered on an unspecified date. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021067674 maternal, infant cases;US-PFIZER INC-2021068772 maternal, infant cases

Felt a slight flu-ish the following day. 4 days after, I had Aches, headache, severe sneezing, congestion that was painful coughing and difficulty breathing. Right Leg aches.

Hard to breath right chest but took inhaler and was better. Hives took 50 mg of Benadryl at sight then after one hour went to primary Dr to get checked out. Was told to take 25-50 mg of Benadryl every two hours and Pepcid 20 mg one tablet 2 time daily, itchy burning eyes use eye drops, come and go since 01/29/2021. I get really tired and upset stomach also 2/09/2021

Within 45 minutes experienced throat tightness, shortness of breathe. Less than 4 hours later, experienced diarrhea and abdominal pain. Less than two months later, my right shoulder dislocated and am now having issues with range of motion, pain and weakness.

Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe

Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted. Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided. She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction. Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.

Went to get the vaccine, sat down and received it in her left arm, and while waiting for the 15 minutes and after 10 minutes she stood up and coughed, a nurse came to her and asked if she could help her, she grabbed her throat and told her she could not breathe. She gave her an Epi-pen shot in her right thigh and then she put oxygenation on her finger, around 5 minutes later they took her to the ER. She felt fine immediately after the. The nurse then gave her an IV but they did not give her any medicine. She also had her BP monitored and checked her vitals signs, and a doctor talked to her and kept her for an hour for monitoring, and then released from the ER.

Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Tightness in the chest, throat, ears, and head with a feeling of dizziness started on the 4th day after receiving the vaccine. Feeling extremely fatigued and difficulty breathing. Falling asleep whenever and wherever. Rashes all over the body including the face that come and go. Burning pain and a feeling of flushing when the rash develops. Waking up in the nights with the rashes and itchiness that is unbearable. Experiencing difficulties staying focused and complete a single task. Off from work for a week now due to continuous dizziness.

Itching, stinging rash on arms, bump above injection site with swelling on left arm, throat thickening but not closure

got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being taken away and the taste (just like after getting an IV cleaned with saline). Nurses told me to sit up front to be observed and waited 30 minutes. After the 30 minutes, I began getting very warm (went outside to get fresh air); went to vehicle, took mask off face, was still feeling very hot, Face was bright red, lips were very red (looked like I had on makeup and I didn't have any on). Took 4 children's Benadryl (dissolvable). Went back to work. redness started to go away. Throughout the morning, I continued having the feeling of breath being taken away and the taste. It wasn't as bad, so I didn't worry. My lips were not too swollen, face was still swollen. I have had MANY reactions to food allergies and didn't wanna "cause" a scene. By 1:30, I was in a meeting trying to talk and my tongue started to feel thick and it was harder to talk. I took 2 adult Benadryl's and tried to work some more to keep my mind off of the reaction. I ended up being very tired and laid down. I slept till about 5pm and seemed okay after. Nothing else was done. My muscle was sore, no other symptoms.

itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat

Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; slight dizziness and states " feels like having anxiety."

After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored. About 2 hours later I was released.

Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM and Benadryl IV, transported Hospital.

Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.

pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.

1150AM Swelling throat feels she cant breathe, she refuses Epi pen says it may anxiety 1203 pm Given Benadryl 25mg po vitals stable 1213 Given Benadryl 25mg po, rest in supine position. 1230 feels more relaxed swelling in throat still a little scratchy. 1300 scratchy/swelling resolved. 1320 Sat up on exam table feels fine. ER precautions given, Exited in stable condition.

S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness and facial flushing after 16:10 after Pfizer vaccine that was given at 16:10. First dose of vaccine. No SOB. O: Pt flushed, arms reddened and feeling uneasy. B/P 130/100, Pulse 98. RA STATS 99%. RR 16. Lungs CTA. Benadryl 25 mg PO at 16:29, water and reassurance. B/P at 16:41 126/82, Pulse 94, SATS 100%, Lungs clear, B/L arms normal color. Hands remained chapped and reddened (too much hand washing per patient). A: Mild allergic reaction to Pfizer vaccine, first dose. P: 16:56, patient improved, refused further care, refusal form signed and instructions given for post care and worsening symptoms. Pt discharged to home via W/C to care. Instructed to F/U as noted.

face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.

Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.

heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.

About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so she received 50mg of Benadryl PO. About 10 minutes later she said that she thought it was helping. About 20 minutes after the benadryl she started having dizziness/lightheadedness, visual field narrowing, worsening throat swelling with frequent throat clearing, and tingling in her hands, epinephrine pen given L thigh. After 5 minutes without improvement Epinephrine pen given R thigh. No rash/hives noted. Vitals were stable the entire time with SpO2 of 100%, RR 18-22, HR 84-98, BP 100-138/60-86.

Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.

A few hours after the vaccine the pt became short of breath and wheezy, shortly after became itchy. She used her albuterol inhaler, took Benadryl and went to sleep. Today her itching returned today and she devolved a rash and hives. She came to the ER, was treated with Benadryl, Pepcid, methylprednisolone, and IM epinephrine, and IV fluids. Her symptoms resolved in the ER and she was observed x2 hours, and discharged with a prescription for oral steroids.

Skin became hot, burning, difficulty swallowing, difficulty breathing, anxiety, dizziness, light headed. Took benadryl po 50 mg. Was seen at ER. Received albuterol neb, steroids IV, and prevacid PO. Sent home with po steroids and benadryl. S/S improved after treatment.

o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.

Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021

I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.

2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then irregular heart beat, rash on neck and chest. Nurses administered 50 mg Benadryl. 10 minutes later, heart racing again and inability to catch my breath. Dizzy and light headed. Irregular heart beat. Pulse ox was ok throughout. Total time of nurses observing these symptoms was 45 minutes. Two days later, still light headed and dizzy.

Patient verbalized to vaccinator she was feeling shortness of breath immediately after receiving 1st dose of Pfizer vaccination. Patient became diaphoretic. Vital signs monitored, EMS activated by site lead, patient remained safe, husband contacted and came into facility to retrieve patients belongings. EMS arrived and assessed patients vitals. Patient transferred to Hospital for further evaluation. Vital signs upon transfer B/P 134/75, HR 76, O2 saturation 100%

Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about 10 minutes. Still feeling very fatigued.

Patient complained of nausea and lightheadedness about 15 minutes after receiving the vaccine. She denied itching, hives, swelling of tongue or throat. Did not feel faint. Approximately 30-40 minutes later she had improvement of nausea and lightheadedness but felt some swelling on left side of throat. Physical exam still WNL. She declined paramedics. She wanted to leave and was felt to be stable. Did not become syncopal on standing. She is "7 belted mixed martial artist." Planned to return home and possibly take Benadryl. Left at approximately 3:50pm

1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't think much about it. I went to work, thought was a sinus infection. Went home, and felt horrible. 1/14 didn't feel great but went to beach for my birthday. It went downhill from there. I got really really sick really fast. 1/17 rapid test; positive. *still very fatigue, hard to describe the feeling. I get winded really easy. **it really did affect me; 'put me in a dark place' / the mental part is really worse then the body part.

1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE. EMS CALLED. EPI VIA IM (PEN) ATTEMPTED X3, 3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.

Patient felt faint nearly immediately after but said she wasn't having problems breathing. She was told to breath deeply and she quickly started feeling "a little better" so she was helped to a chair with arm rests in the room. She said she had an orange in her bag, so she started eating her orange. Just a minute later she said she was going to pass out, so the pharmacist caught her. He held her up in the chair and tried to revive her for a few moments but noticed that the blood was draining from her face and her lips were turning blue so yelled for one of his technicians to call 911 and the other to grab an epi pen. He then lowered her to the floor in case he needed to begin to resuscitate while the technician brought him the epipen. While lowering her she urinated on herself. As the pharmacist went to check her vitals before administering the epipen and beginning cpr if necessary the patient suddenly gasped once and her eyes opened widely, but not continue to breath. Upon inspection in her mouth there was a piece of orange near the bottom of the throat. The pharmacist asked if she was choking and she did not response at all, but did not start visibly breathing either. So the pharmacist swiped the piece of orange out quickly, in case it was either previously lodged or patient would have to be resuscitated. She did not seem to enjoy this and this seemed to wake her up and she quietly gasped not choking. She started to quickly improve and admitted that she was feeling better, and had passed out before after getting blood drawn but never after a shot so didn't mention this. While this was happening a police office was going through the drive through so the technician called him in for assistance and he arrived around this time. He asked her a few questions like "what's her name, who's president, how many quarters are in a dollar" which she was able to answer. She said she was mostly embarrassed and was feeling much better. She sat up in the chair again about the time the emts came in. The checked her out, but she didn't want to go to the Emergency Room. She was driven home by her father. I called her later around 6 pm that night and she said she was feeling totally fine and I advised her to please call her PCP and discuss this incident with him or her.

Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.

Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt mentally foggy. As the day progressed, I felt a fullness in my throat and fatigue. Over the next week, the dizziness became worse, I experienced intense headaches and shortness of breath for several days. I had difficulty sleeping and vivid dreams. I have had thyroiditis twice in my life after giving birth to my 2 children with similar dizziness and throat fullness. I decided to contact my doctors and had my thyroid levels checked. My TSH was abnormal and my doctor thinks I could be having another episode of thyroiditis. My menstrual cycle arrived a week early. Following this, I continued to have dizziness, throat fullness, and intense headaches. I developed sore breasts and breast discharge as well as in increase in frequency of urination. I decided to postpone the second shot until I was feeling better as past episodes of thryoiditis took about 2 months to resolve. My next menstrual period was a week late, also accompanied by mood swings, breast tenderness and intense headaches. SIx weeks later, I continue to experience occasional dizziness and throat fullness and increased urination. Prior to the vaccine, I was feeling fine and it seems like the vaccine triggered some kind of hormone/endocrine response in my body. I have not had reactions to any vaccines prior to this. I am quite hesitant to receive the second vaccine and am wondering if I should wait a period of time and try something different such as the Johnson and Johnson one. I? not quite sure what in the Pfizer vaccine ( perhaps the mRNA?) could have triggered this reaction in my thyroid and endocrine system. and would appreciate guidance on what to do next as I would like to be fully protected from COVID-19 but do not want to endure these unusual side effects.

1/10 vaccination I was in the 15 min observation, my throat tightened up. I thought anxiety. I left and feeling never went away. Wheezing, coughing. Dr. informed me I had exercise induced asthma. called pcp 10 days later when symptoms not going away 02/2021 ENT; allergic reaction. Inhalers, antihistamines. No skin reaction tests. Suggested to get 2nd vaccine. *still having tightness in throat

Resting heart rate in the 140s, normally in the 80s with heavy pressure on chest started 1 day after shot and lasted for 2 days followed by asthma symptoms.

About 5 minutes after patient came back out into the waiting room she waved the technician over saying she was not feeling well. RPh went out to her and she reported feeling light headed and having trouble breathing. Her breathing did not sound labored and she had no swelling anywhere. We asked her if she wanted us to call an ambulance and she declined. She reported that she had not ate or drank anything all day so we gave her some OJ and a granola bar. She sat in the waiting room under RPh and technician supervision for about another 20 minutes until she eventually felt ok enough to leave and drive.

Shortly after the vaccine was administered, pt endorsed feeling as if a "lump" was in her throat. Felt some tightness with swallowing. No SOB, wheezing, nausea/vomiting, urticaria. Normal vitals and exam, post oropharynx clear, no angioedema and no wheezing on exam. Pt given oral Benadryl, a nd observed in car for 30 minutes prior to discharge

Client was in the monitoring room after receiving first dose. Reported to the nurse felt like throat was swelling and having difficulty breathing and swallowing. Nurse reported client was visibly having a hard time with breathing. Client reported felt weak and legs felt "like noodles." Epi Pen given Left thigh. 911 called . Client accepted transport for further evaluation.

Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.

Pfizer-BioNTech Covid 19 Vaccine EUA Tight throat about an hour after vaccine injection. Tight throat lasted 14 days. Took ibuprofen . Itchy all over after 24 hours. Lasted 14 days

Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium

Patient is a 41 Y female who presented today for COVID Vaccine c/o of scratchy throat, throat tightness hoarseness, able to speak in full sentences, able to drink water without difficulty remains on RA no hives/rash noted, monitored closely. States throat tightness is resolving, remains on RA. 1133-patient states symptoms continue to resolve, and is ready to for discharge. BP 153/99 Pulse 81 Temp 97.4 °F (36.3 °C) (Temporal) SpO2 99%

Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.

3-24-21 7:06PM PT STATES 'CHEST TIGHT/PRESSURE, SOB, NAUSEA & LIGHT HEADED'. A/O, W/D, RESP REG WITH EASE. NO DIFFICULTY SWALLOWING. NO ACUTE/OBVIOUS DISTRESS. 7:15 AMBU TO BATHROOM. 7:26PM STATES SHE 'FEELS BETTER AND OK TO GO HOME'. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. RESP REG WITH EASE. NO DISTRESS NOTED. 3-25-21 8:15 TC: PT STATES SHE IS 'ALL BETTER TODAY'.

I experienced left sided chest pain 2 days after the vaccination lasting 2 days. Then 4 days after the vaccine, some back/Lung pain causing difficulty and painful breathing lasting for at least 3 days. I went to the Emergency department 6 days after the vaccination. I am reporting this information on the 8th day of vaccination.

24 hours later, I developed issues with my throat. I have spasms that feel like my throat is tightening up. This has been going on for 3 weeks. I have trouble swallowing and i constandly feel like something is stuck in my throat.

This could certainly represent allergic reaction which she has had the vaccines in the past. She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours. At no point did she worsen or express a desire to have an additional epinephrine dose. She was never hypotensive. She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76

2 days after 2nd dose all day moderate headache and nausea, 3 days after 2nd dose woke up at 4am with tingling in lungs and shortness of breath.

41 yr/o female covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vaccinee Throat tight, hot, scratchy Tingling sensation No swelling sensation No rash, itching No dyspnea, wheezing Got benadryl 50mg IM Mild improvement

Red rash formed on left neck within 14 hours. Rash worsened day-by-day to where it infected all body parts, especially the face and neck. Intense itching and redness. Shortness of breath on day 7 and 8. On day four, prescribed two Zyrtec a day and Triamcinolon. On day seven, prescribed Prednisone. On day nine, prescribed Hydroxyl, Epineprine 0.3 MG/INJ AMNE, and Aug Betamet 0.05% Oin Foung

Initial dizziness, light-headedness, brief shortness of breath, elevated heart rate 2 days of flu symptoms: mild fever, chills, nausea, diarrhea, headache 10 days (so far) of heart palpitations, elevated heart rate, and spikes in blood pressure

Status post vaccine- hyperventilation, shaking. patient c/o trouble breathing had some patchy redness to neck which resulted in epinephrine being administered IM per Dr. Epinephrine administered at 1831. BP 138/82 HR 78. PT was transferred to the local ER for further evaluation and was released at the ER.

Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.

While walking to the observation area after I got the vaccine, I became lightheaded and short of breath. I needed assistance to a chair. Things began to spin, voices sounded far away, I felt like it was hard to breathe and my throat began to close up. I felt really hot - my clothes were soaked with sweat and my husband (and the paramedics) said I was bright red. I genuinely believed I would pass out. When I sat for a minute with my head back I felt more stable. Then I felt like I had pins and needles all over my body, worst in my feet. The symptoms felt like they came in waves - once I sat down I felt less dizzy, but still struggled with my breathing. When one thing got better, another would intensify. After a couple of minutes my breathing felt much better and I got a metal taste in my mouth and my feet really hurt with pins/needles. The whole thing lasted about 8 minutes, when although I felt tired and my clothes were wet, my body felt safe and almost back to normal. I was surrounded by nurses and paramedics who monitored my vital signs and had medicine nearby, but never administered anything. My body recovered on its own and after 15 minutes I felt great and I gathered my things and drove home. The EMT who said goodbye encouraged me to call my doctor if I felt I was getting worse.

At 1555 participant walked back into Vaccine Site covid monitoring area and c/o SOB & tongue edema; was post 1st Pfizer Covid vaccine at about 1525. At time participant escorted to monitoring cot and laid down. She explained experiencing chest tightness and feeling of tongue swelling upon exiting building post vaccine; she attempted to sit in car until s/s ended but no improvement. 1555 B/P 151/ 85, P 79, O2 Sat 99% with noted tongue edema / SOB. 1558 Called 911 and on site clinical assist alerted. 1559 Benadryl 50 mg IV given via left deltoid by RN. 1600 BP 140/82, P 71, R 18, O2 sat 99%. Noted allergy hx; yeast, mold, grape seed oil. 1603 Participant voiced feels decrease in tongue swelling and more relaxed feeling; no noted skin redness - BP 122/89, P 70, O2 sat 99%. At time EMS arrived on scene and began assessment. 1610 EMS assessment completed and participant declines transport to hospital; voiced will monitor self at home & call 911 if s/s return. 1614 BP 140/83, P 73, R 18, O2 sat 99% with visible noted decrease in tongue edema. 1615 Participant remains semi reclined on cot and making attempt to contact husband for transport home. 1619 took few sips of H2O with no difficulty swallowing. 1626 BP 115/91, P 62, O2 sat 99%. 1629 Attempted to stand participant and noted c/o dizziness, HA and feeling that tongue edema was returning; returned to cot in lying position. Assessed; clear lungs, noted increase in edema, no SOB - O2 sat 99%. 1630 EMS called to site; BP 148/96, P 62, O2 sat 99%. 1637 EMS arrived on scene and resumed care. 1641 Participant leaves site via stretcher with EMS for transport to hospital. Participant's husband arrived on scene and given participant's purse and car keys per her approval.

TIREDNESS, MUSCLE PAIN, CHILLS, SWEATS, JOINT PAIN, FAST HEARTBEAT, DIFFICULTY BREATHING, WEAKNESS AND DIZZINESS

Pt received first dose Pfizer vaccine at 1528, at 1550, pt was in observation area and reported feeling "strange" like her throat was tight. Pt has PMH of anaphylactic reaction to multiple medications and foods. Nurse encouraged pt to begin pursed lipped breathing. At 1552 pt became SOB and felt her throat "closing". Administered 0.3mg Epinephrine IM to L quadriceps muscle, applied O2 via mask running at 12L and called 911 for ER transport. BP 138/72, HR 100, O2 sat 99% temp 98.2. Paramedics arrived at 1558, pt was stabilized and transferred to higher level of care.

After 15 minutes c/o left sided headache, left neck pain, tingling in feet and felt like her "throat was closing". Medicated with 60 mg Allegra as per vaccine protocol. O2 sat in 100%. Transported to ER in wheelchair in no acute distress.

Pfizer-BioNTech COVID-19 Vaccine EUA 41-year-old female with history of anaphylaxis to fish and cashews, asthma, aortic stenosis, eosinophilic esophagitis, and chronic idiopathic urticaria presenting to emergency department for chest tightness, dyspnea, nausea, vomiting, and throat discomfort following 1st dose COVID-19 vaccination (Pfizer). Vital signs remained normal and stable during this ED visit. On presentation, patient was in moderate distress. Physical exam was notable for retching and tachypnea upon arrival. Patient's presentation consistent with anaphylaxis likely due to COVID-19 immunization (Pfizer). Epinephrine, famotidine, benadryl, solumedrol, zofran, and fluids administered with complete resolution of symptoms. Patient observed for 4 hours without worsening of symptoms. Patient discharged home.

Patient received 1st dose ofCovid vaccine & was anxious about receiving it. I gave the vaccine at 10:40 & She started to have tingling in her hands about 15 mins after. I took her blood pressure at 11:00am because she was getting dizzy/lightheaded. It was 135/85 & her pulse was 85 so I believe she was getting more anxious. At 11:05 she stated that she was having trouble breathing, so I confirmed with her several times that she was having trouble breathing & gave EpiPen in left leg 0.3mg then called 911. She felt like she was breathing easier but was going to pass out so had her lay on her back with feet elevated until paramedics arrived.

Patient developed rash, itching and throat swelling shortly after administration of 2nd Pfizer COVID vaccine dose. Treated with IV Benadryl 50mg, symptoms resolved within 15 min.

angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Within 5 min of receiving the shot there was a minor itch such as a tag rubbing my neck. I am not an itchy person so I noticed it right away, but ignored it. Then with in the 10 minutes I felt an elevated breathing as if one were hyperventilating. I told myself that I was probably anxious any that too went away within 3+ minutes. The itch continued to increase after leaving the site, and by 6 pm it had become like an ?morphine drip? type itch . An itch that you get after a procedure in a hospital and they give you opioids. An annoyance but harmless. This has continued for 3 days. After the first day, I asked a pharmacist what would be recommended for the itch. She suggested benedryl. It worked for a short period of time 1 1/2 hours. Calamine lotion was also tried with a cool shower. After the 3 day I went to the urgent care where no testing was done, but I was prescribed hydroxyline

Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, difficulty in breathing, coughing and gagging while in our observation tent. Client was brought inside by wheelchair to our emergency area for further evaluation. Client was answering questions, pulse ox read 100%, pulse 106. Client had increased complains of tightness in throat, was coughing. 4:11 pm- 0.3 Epi pen given in right thigh. Lot # OFM534, exp: 9/20222. Call made to 911. Client then lost consciousness, eyeballs were fluttering underneath lids. Sternal rub- did rouse client, but then she became unconscious again. Daughter then reported a history of allergy to MRI dye, Pulse 110, 2 L O2 started. Client remained unresponsive, but was breathing normally. 415- call to Dr to assess whether Benadryl should be given or not- since client was unconscious. 415 shaking/chills began, and daughter reported history of non-epileptic seizures, but none since 2019. 416pm EMS arrived- IV started and seizure #2 witnessed by EMS. Seizure meds given per EMS- client transported to hospital.

Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Embolisms in both lungs; transferred via ambulance as medical emergency to another hospital for treatment Released from hospital on 4/11/21 and currently under treatment

Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off. Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).

delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.

extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ep7533/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:30 (at the age of 41 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 11:15, the patient experienced extremely dizzy, throat swelling, and anaphylactic response. The clinical course of the events were as follows: 45 minutes after receiving COVID-19 vaccine, the patient was extremely dizzy, then had throat swelling, and anaphylactic response. The patient was admitted to ER and given treatment with epinephrine, steroids, albuterol, nubulizer, and blood. The events dizzy, throat swelling, and anaphylactic response were considered serious as requiring an emergency room visit and hospitalization for 1 day. The patient received treatment for these events. The outcome of the events dizzy, throat swelling, and anaphylactic response was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report. Information on the lot/batch number has been requested.

The patient received the Pfizer COVID vaccine and did not have any apparent reaction initially. Sixteen days after vaccination, the patient developed pain in her neck and shortness of breath. ER evaluation revealed a DVT in her right brachiocephalic vein and acute pulmonary embolism.

Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakiness, and then a tightness in her throat associated with "gagging."

asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included anti contraception (unspecified product). On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows: on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure and dizziness. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021477200 mother/baby

sinus congestion, post nasal drip headache fatigued and winded at times, congested and sinus pressure

Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight gain of 2 pounds overnight; Rash on chest; Rash on chest, possibly due to tape (dermatitis contact); Heart palpitations; Oxygen saturations dropped to 85% on room air; Diarrhea; This is a solicited report based on information received by Pfizer. A contactable consumer reported that a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 03Mar2020 to an unspecified date at 0.041 ug/kg, then at 0.045 ug/kg with therapy dates unspecified, and then at 0.049 ug/kg with therapy dates unspecified, for primary pulmonary arterial hypertension; and macitentan (OPSUMIT) on 11Jan2021, orally from 11Jan2021 at 10 mg, 1x/day for primary pulmonary hypertension. Medical history included ongoing primary pulmonary arterial hypertension. Concomitant medication included sildenafil citrate. On 15Jan2021, the patient had a blood clot in neck. The patient was hospitalized from 15Jan2021 to 16Jan2021 due to the blood clot in neck. It was reported that on 15Jan2021, which is 10 months 13 days after initiating IV Remodulin, the patient was hospitalized due to blood clot in her neck. The patient went to the emergency room on 15Jan2021 and she was planned to be admitted to change her catheter, later she was hospitalized on the same day and her Remodulin central line was changed as per the prior plans of getting the catheter changed. The patient was discharged on 16Jan2021. The patient then had a rash to her chest (dermatitis contact previously reported) that started on 20Jan2021. The patient believed it was from the original dressing that was placed after her catheter was replaced. The rash to left chest around her Remodulin catheter line (dermatitis contact previously reported) was also reportedly itchy at night. On an unknown date in 2021, the patient's oxygen saturations dropped to 85% on room air (oxygen saturation decreased). The patient continued to have rash on her chest (dermatitis contact previously reported). On 29Jan2021, 10 months 27 days after initiating IV Remodulin, the patient was in the emergency room due to increased shortness of breath, pressure on her chest, edema in her feet and a weight gain of 2 pounds overnight. All the tests were negative but during walking test, the patient's oxygen saturation dropped to 85% on room air. The patient was advised to wear mask continuously. 2 weeks after receiving the first COVID-19 vaccine, the patient had heart palpitations, shortness of breath, and chest pressure 2 weeks after receiving the first COVID-19 vaccine (dyspnoea and chest discomfort previously reported). The patient went to the ER (emergency room), had worked up and was seen by a pulmonologist, nothing was found, and the patient was released home. The prescribing physician's practice ordered her to wear oxygen (O2) continuously. The patient said that she only wears it when she leaves the house and at night and was fine. She felt this episode was related to the COVID-19 vaccine and was not receiving the second dose. The patient stated that her physician had took her off the Opsumit due to shortness of breath (dyspnoea previously reported). The events 'blood clot in neck', 'shortness of breath (dyspnea)', 'pressure on her chest', 'edema to her feet', 'weight gain of two pounds overnight' and 'heart palpitations', resulted in emergency room visit. The event, 'diarrhea', was controlled with diphenoxylate and atropine (LOMOTIL). The patient had a walking distance test on an unspecified date in 2021 (results were not provided) and weight was 209 lbs on an unspecified date in 2021. The events, shortness of breath (dyspnea)', 'pressure on her chest' and 'heart palpitations', was reported as serious (medically significant). The events rash on chest, and rash on chest possibly due to tape (dermatitis contact) had not resolved while the outcome of the rest of the events was unknown. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Mar2021): This is a follow-up solicited report based on the information received by Pfizer. Additional information included medical history, suspect drug data, reaction details and clinical course details. Information on the batch/lot number has been requested. Follow-up (04May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the available information the events are most likely related to an intercurrent or underlying condition which is not related to the subject drug. There is a reasonable possibility that the drug contributed to occurrence of the event rash. The follow-up information received does not alter the previous company clinical evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.

Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site

Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.

Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.

Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)

Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.

About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.

Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She was given benedryl and epinephrine and EMS was called.

About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.

Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.

After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.

Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.

Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.

patient began to have headache (pressure back of head), some shortness of breath with an elevated blood pressure. Patient stayed for monitoring for 30 mins and symptoms aleviated

While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".   Pt stated that her heart felt like it was "pounding".   VS: 162/96, 99% RA, HR in the 70's.   Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.   The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist.   Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.  

TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PATIENT RELEASED SAME DAY

Day 1 Started with throat itching followed by cough with in 20 mins post vaccine later in evening left lung pain with SOB Day 2 Shortness of breath , left lung pain, cough Day 3 - Day 4 PVCs Taking Zyrtec and Pepcid for 4 days , Evaluated by EMTs onsite , did allergy treatment and evaluated by PCP

wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital

Was unable to swallow, breathing was not affected. Throat muscles felt weaken. Was given a Benadryl, symptoms resolved soon after.

2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.

reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.

headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.

Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.

Patient received Pfizer COVID-19 vaccine without any immediate complication on 1/14/21approx 1455, was then escorted to observation area for a 30 minute observation time. Pt had previously had a known reaction to contrast media. Approximately 5 -8 minutes into observation, pt had one audible cough. Nurse asked patient if this was a new onset cough. The patient stated she would try to "manage" cough. Pt escorted to bay for monitoring. Pt developed shortness of breath and wheezing rapidly. Rapid response team called and local 9-11 also called. Pt received albuterol nebulizer treatment, placed on O2 at 8L. O2 sat 99%, HR 115-120. Respiratory therapy assisted and Rapid Response Team monitored pt while waiting for EMS. Physician order to give Epinephrine 0.3 mg IM in right deltoid, given as directed at approx 1515. Second epinephrine 0.3 mg IM given approx 1530-1535. HR 144, O2 sat 99%. Patient transported to local ER, pt intubated approx 1927.

Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and needs to tilt head up. Advised patient to sit under observation. At 11am continues to have throat soreness and light shortness of breath. Continues to need to tilt head up. Light tingling around throat. Has never felt this before. No dermatologic symptoms. Moved her for observation at ED at 11:30am

from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and started driving home I began to notice that my face was slightly numb (Iike I'd had too much novicaine). This was maybe 20-25 minutes after the dose. When I was home I also noticed that the back of my throat felt a little swollen. This probably lasted for a couple hours.

Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea

Less than 2 min after administration developed throat fullness and difficulty swallowing. This persisted. Never any wheeze, never any SOB

About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.

At approximately 30 hours after the second dose, had acute onset of mild-moderate chest tightness, drop in peak flow (~20% decrease) and coughing. This was treated with a single dose of Albuterol 2.5mg/3mL nebulized with complete resolution. No further shortness of breath. (Concurrently, also had mild tiredness and muscle aches.)

Approx. 30 hours after this vaccine had acute onset mild-moderate shortness of breath, coughing and drop ~20% in peak flow. This was treated with a single dose of albuterol 2.5mg/3mL nebulizer. Concurrent also mild tiredness, muscle aches and headache

10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER

Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration, patient became short of breath, dizzy, light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time. 12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.

Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.

Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no other vitals available), gradually improving over about 30 minutes, followed by severe fatigue

5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone

14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.

Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.

Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or occluded

Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.

Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.

About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.

Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.

Systemic: tight throat was given 50 mg of benadryl and water and recovered with an hr; symptoms lasted 1 day

chills; heart rate shot up to the 120's; chest pressure; felt like I couldn't breathe every time I stood up; This is a spontaneous report from a contactable nurse (patient). A 42-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date: unknown), intramuscular on the right arm on 29Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included occasional premature ventricular contractions (PVCs) and high blood pressure. The patient had no known allergies, is not pregnant and had no COVID prior vaccination. Concomitant medications included vitamin C [Ascorbic Acid] (VITAMIN C [ASCORBIC ACID]), vitamin D3 (VITAMIN D3), bromelains (BROMELAIN), quercetin (QUERCETIN), zinc (ZINC), acetylcysteine (NAC [ACETYLCYSTEINE]) and Probiotic. The patient had no other vaccines in four weeks. On 06Jan2021 at 21:00, the patient experienced chills all day but no fever. Around 9pm, her heart rate shot up to the 120s and she had chest pressure and felt like she couldn't breathe every time she stood up. When she laid down, it was better. These lasted about 3 hours. She had some very mild shortness of breath twice after this on the 7th and 9th, but it was not nearly as bad as on the 6th. The patient did not take any medication when these happened. The patient tested for COVID post-vaccination (07Jan2021) through COVID-19 PCR (Nasal Swab) which resulted negative. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.

Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.

12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose

Allergic reaction; This is a spontaneous report from a contactable consumer (patient's spouse). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 14Jan2021 15:00 at a single dose in a hospital for COVID-19 immunization. Medical history included allergy to sulfur and latex. There were no concomitant medications. The patient previously took dexamethasone (DECADRON) and experienced allergy. The patient had Covid vaccine at the hospital yesterday (14Jan2021) about 3pm and around 315-320, she had an allergic reaction. The patient was given epinephrine and stuff like that but ended up having to call an ambulance and took to another hospital. There, they had to put her in ICU and on a ventilator. The patient's spouse asked what might have been in the product that she would have been allergic to. The patient was transferred to hospital. She is a respiratory therapist. The patient was treated with epinephrine, albuterol and she was put on a bi-pap but she couldn't breathe and was told by the doctors that her body can't take it so they intubated her about 7:30 pm, she was put on a ventilator. The patient had an emergency visit. The patient had no prior vaccination (within 4 weeks). The outcome of the event was not recovered. Information about lot/batch number has been requested.

approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my heart racing, throat swelling, chills,weakness, tired, pain and swelling at injection site(right arm)

13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.

(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department

12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.

blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

15 minutes after received COVID 19 vaccine, developed shortness of breath, dry mouth and throat dysphagia, high blood pressure and anxiety.

shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 04Jan2021 at 15:30 at single dose for COVID-19 immunization. The patient medical history included allergies: shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 04Jan2021 at 15:45, the patient experienced several episodes of racing heart, shortness of breath, chest pressure and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. Therapeutic measures were taken as a result of the events and included treatment with albuterol. The patient outcome of the event was recovering. The information on the batch number has been requested.

-ADR: Allergic reaction (SOB and throat tingling/swelling -Inpatient - 0.9% NaCl Bolus, famotidine (PEPCID) injection 20 mg ,diphenhydrAMINE (BENADRYL) injection 25 mg, methylPREDNISolone sod succ (SOLU-Medrol) injection 125 mg, diphenhydrAMINE (BENADRYL) injection ADS Med, famotidine (PEPCID) injection ADS Med -Treatment: discharged with Benadryl and Medrol Dose pack

chest tightness and nausea, hyperventilation, 1st dose pfizer vaccine @ 1610, benadryl 25 mg IM given

Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help. It lasted about 4 hours. Shooting nerve pain through my body for several days. Overall sluggish for two days, body aches, exhaustion.

I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.

I was in observation for about 45 min due to the symptoms I had with the first dose. About 10 min after vaccination, I felt itching on my face, and it progressed to my back and hands. I also started coughing, no rash. In the evening, at home I started feeling shortness of breath and started using my albuterol inhaler and symbicort. I had a feeling like someone was sitting on my back, squeezing my left side, my left lung. I also experienced chest pain. I had to use symbicort and albuterol for about 5 days and the symptoms persisted for at least 3 days, itching, cough, chest pains. The symptoms went away and they returned 3 days ago. Now I am once again starting to experience cough and shortness of breath.

After receiving vaccine, pt started experiencing red face, itchyness, and shortness of breath. Pt was examined and took 50mg benedryl that she brought with her. Within 5 minutes of taking benedryl, she stated she was feeling better. Redness went down along with itchy feeling around her neck and chest.

Information provided by patient as follows. I do not have access to urgent care notes to provide that information. ALLERGIC REACTION TO VACCINE. SWELLING IN INNER AND OUTTER BOTTOM LIP. THROAT AND EARS ITCHY AND THROAT FELT TIGHT. DIFFUCULTY SWALLWING. WENT TO URGENT CARE AND RECEIVED STERIOD SHOT.

I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was given IV and steroids. The symptoms lasted for 6 weeks.

extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off

Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives traveled down the left side of my body. I sought treatment at Urgent Care. They prescribed 4 mg pack of 5 day steroid. On Saturday morning, the hives returned worse and covered my entire body except my face. The injection arm was swollen and red. I also begin to have shortness of breath. I went to the ER and they gave me an IV of benedryl and prednisone. I was released with another 4 day course but with 20 mg of steroid .

About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm, I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand. Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.

The patient presented to the Emergency Department today secondary to symptoms which she states started about 1 hour ago prior to arrival after she received her Covid vaccine first injection at 11:40 AM, states that she went back to work as a teacher and started to feel a sensation as if she had some swelling of her throat and a mild sore throat as well, she states that she developed some nasal congestion as well as lightheadedness, she denied any dyspnea, no coughing or wheezing, no chest pain, vomiting or diarrhea, she called her doctor and was told to present here for evaluation, she did not take any medication for symptoms prior to arrival and states that her symptoms are very similar to her previous allergic reactions but has never required epinephrine. Treatment required: NS1L IV bolus, Famotidine 20mg IV, Solu-medrol 125mg IV, and Diphenhydramine 50 IV all x1. The patient will be given a prescription for a short course of steroids at home and has been advised to take benadryl and pepcid at home if needed.

Pt reporting SOb and palpitations. Her vital signs were normal. she felt better after drinking juice.

Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.

Pt received vaccine and reported red blotches on arms and started feeling faint. Pt reported dizziness and headache as well as difficulty breathing. Vitals: 1156 112/71, HR 62; 1208 116/72, HR 62. Pt observed for 30 minutes on stretcher. At 30 minutes, pt reported feeling ok to leave and was wheeled out of facility and ambulated to car.

08:03- Vaccine administered at Hospital in ED. Observation time increased to 30 minutes related to history of anaphylaxis. 08:18- Pt complains of difficulty swallowing and feeling as though throat swelling. Patient placed on monitor. O2 sat 98-100% on room air. Epi 0.3mg administered in left outer thigh at this time. 09:21- Patient continued to be monitored in ED but not registered as an ED patient. Patient denies needing to be seen by provider. Symptoms resolved. Patient states "I'm fine. I'm better than fine, I'm great." 09:25-Patient discharged from observation. Instructed to return to ED or call 911 if symptoms return. Patient voiced understanding.

Approximately 20-25 minutes after injection, dizziness, tingling in face, and throat tightness occurred, which resolved after about 15 minutes. No shortness of breath experienced and symptoms were not severe enough to seek medical treatment.

Patient reported arms and legs being itchy approx. 10 min post-injection. Administered 50mg Benadryl orally. Patient also complained of tightness in throat, which improved after Benadryl. Vitals did not indicate anaphylaxis, continued to monitor BP over course of symptom reporting. Also applied ice pack to left forearm and back of neck. EMTs arrived to check vitals and reported no signs of anaphylaxis, inquired if patient wanted to return home or wanted to get higher level of care, and she chose to go to the hospital. There, the providers found no emergent medical issues. Nurse called and checked on patient 4pm same day, the patient reported no issues and all concerns were resolved.

Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.

Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.

I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.

In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am

On Mar, 25th , around 4.30 pm I got vaccinated. I went back home. I ate my summer and Took Tyelenol as I was tired and arm was little sore. I slept around 7.30 pm and got up at 7 am. I felt weakness and after I had my break fast , my body pains started. Every muscle ached and every joint ached. I had weakness and lethargy. I took tyelenol extra strength so the pain was subsiding . I had temperature 100.3 since Fri , Mar 25th. When the tyelenol was wearing off the pains used to become horrible. I was not able to move and I was on my bed bed most of the time. On 28th I even tried Ibuprofen as Tyelenol was not helping a lot with pains but Ibuprofen did not work at all. I sent messages to my dr who thought these side effects are expected. On Mon she replied if the side effects did not resolve I can go to Immediate Care. My arm was sore but that soreness was nothing compared to body aches I had. I called off from work on Fri and Sat. My employer wanted return to work clearance. I went to discuss with Immediate care doctor as I had same weakness and tiredness and little walking was making me breathe heavily. As it was almost the end of 4th day after I got my vaccine they tested me for Covid and my results were negative. I still have to be in quarantine for 7 days from yesterday. I was tested Covid positive in Mar 2020 around mar 24th. I had same horrible pains but had high temperature like 1049.8 and with tyelenol it was 102.5. I am scared to take the second dose that might trigger same reaction. I suffered a lot like people suffered after 2nd dose. First dose is sensitizing dose but I showed such reaction that means my body recognized the threat and began to fight in first dose then what is the need of second dose that is actually a booster dose. My main concern is I might feel the same way how I felt now. I am still weak and cannot perform my daily activities like cooking and I have 4 kids aged 7- 12 yrs age.

has a hx of Rheumatoid Arthritis and takes gabapentin and Relafan. She states she is immunocompromised. She received her second dose of COVID-19 vaccine on 1/7/2021 without adverse events. on 3/23/21 she developed signs and symptoms of COVID-19 and tested positive for the virus on 3/26/21; she reported the following symptoms: headache, chills, nausea, diarrhea, congestion, SOB, myalgia, and malaise. She was treated with Bamlanivimab infusion on 3/29/21.

Encounter Date: 3/23/2021 Hide copied text Hover for details 245PM Pifzer first dose Vaccination given. 320 Complaining of not feeling well. States she stayed beyond her 15 minutes as did not feel well. BP 119/80 P86 R 18 Pulse ox 100%. When asked how she was feeling she stated she feels something in her throat. Complains of itching to her back. When examined, found many reddened areas with scratch marks over mid back near bra line. Consulted Dr. regarding giving Benadryl 25 mg po. She advised to administer. 325 Benadryl 25 mg given po. Denies difficulty swallowing but states not getting air as well. Lung sounds audible but diminished at bases. Unable to auscultate heart sounds per NP due to acoustics. 335 BP 125/85 P 132 R 22. Pulse ox 99%. States more difficulty getting air. Epinephrine 0.3 mg IM given complains of lip feeling tight. 337 Squad arrived and given report. BP 124/67 P138 R 22. Pulse ox 98%. Shivering from Epinephrine administration. Patient taken to Emergency Department, unable to see records from that facility.

42 yo female with c/o itching to neck/throat, sensation of throat swelling/SOB, dizziness ~1:43 pm. She has prior h/o anaphylaxis to IV contrast and appeared to be very anxious. Pt was given Benadryl 25 mg PO, water, and rested in a recliner. BP 140/80, HR 88, o2 sat 100%. 911 was called as pt's symptoms were not improving and she had travelled to vaccination clinic alone by bus. She remained A&Ox3, was speaking in full sentences, and no swelling or erythema to throat visualized.

Pt received injection of Pfizer Covid 19 vaccine at 10:28 am, complaint of feeling lethargic and coughing noted at 10:45. complaints of sore throat and difficulty swallowing. coughing getting worse, b/p 154/95, HR 133, o2 sat 100. 0.3 mg of epi given in right thigh @10:46, symptoms improved slightly . bp@10:55 145/92, HR 122, o2 sat 100%. patient starts to have difficulty breathing again and cough returned. 0.3 of EPI given again @ 11:00 , still have complaints of difficulty breathing, 125 solumedrol given IM right upper quad Gluteal muscle. patient starts to improve, b/p 143/86, HR 118, o2 sat 100%. patient monitored for an additional hr because she stated that she did not want to be transferred to the hospital due to lack of insurance. monitored from 11: 15 til 12:20. Discharged home accompanied by daughter, B/P @ 1215 127/90, HR 108, o2 sat 100%. Symptoms all resolved no complaints at the time of discharge. she was able to go to the restroom without issues.

Approximately 10 minutes after the vaccination, the nursing staff noted the patient looked unwell. We provided water and APAP 650 mg per patient request. A few minutes later, she reported throat tightness and that she needed her albuterol inhaler but did not have this on her. We arranged to have a prescription sent and expedited to OP pharmacy for albuterol , which she received and administered with minimal improvement. The nurse continued to monitor her and she advised she felt itchy and diphenhydramine 25 mg was administered. Ultimately after over thirty minutes, there was no change in the patient's status. The patient refused the ED stating she had additional obligations at home. A long discussion of risks ensued, patient verbalized understanding and signed AMA form.

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, chest pain, cough, headache, body aches, and low grade fevers shortly after vaccination. She was tested for COVID on ~4/2/21 and on 4/11/21, and both tests came back positive. Patient presented to the ER on 4/11/21 and was admitted for COVID treatment.

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. The next day, she developed fever, was told that she had a sinus infection, and was treated with amoxicillin. Patient tested positive for COVID on 4/7/21 at her primary care doctor's office. On 4/8/21, patient presented to the ER with cough, shortness of breath, fever, chills, and weakness, but was sent home. Patient returned to the ER on 4/9/21 with worsening symptoms and was admitted to the hospital for COVID treatment.

Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.

41/ YEAR OLD FEMALE COMPLAINEDOF TROUBLED BREATHING 10 MINUTES AFTER RECEIVING VACCINE. ON SITE EMS RESPONDED, VITALS BELOW. AFTER BEING MONITORED SHE WASN'T FEELING BETTER AND WAS TRANSPORTED TO RECEIVING HOSPITAL VIA EMS.

Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.

Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.

flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive on 16Apr2021 (blood test) , CXR with unknown result on 17Mar2021. Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.

She began having shortness of breath after getting her second shot. He parents found her dead in her bed this afternoon. No other known comorbidities.

My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included known allergies to Pineapple, Bananas, onions, several environmental allergies; asthma. Patient didn't have COVID prior vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); cromoglicate sodium (ALLERGY) shot; clarithromycin (CLARITIN); mometasone furoate (FLONASE); fluticasone propionate (PROAIR); all taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. Around 8 minutes after vaccine (as reported) patient felt lightheaded, tightness in throat and tingling in her arms and hand. Her heart was racing.132bpm. She told the workers and was taken by ambulance to the hospital. Adverse events start from 05Feb2021 03:15 PM and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent car. Treatment received included Oxygen, benadryl shot. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.

Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.

fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.

Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).

5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt throat swell. Not lymph nodes. Swelling sensation Inside throat. Had a mild headache. Was given 50mg of Benadryl. Taken to ER for observation. Swelling resolved couple hours later without any further reactions. Swelling never impeded my ability to breathe.

Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl given at 1614. 1615 Epi in L thigh. Pt transported to ED by wheelchair

ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest tightness. The patient is an employee and received her COVID-19 vaccine, first dose 20 minutes prior to ED arrival. She subsequently developed chest tightness and wheezing. She used he albuterol r inhaler and now feels improved. She says that she has been having increased asthma exacerbations lately because of the change in weather. She has had no prior allergic reaction to any vaccine. She denies any hives. Denies any throat tightness. Her symptoms at this point have resolved. Monitored in ED x 4 hrs. No treatment.

RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.

Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.

Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.

Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved

first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU

sob, headache, fatigue, joint /muscle pain, fever. Worst part is the right shoulder joint/muscle pain. This pain is very bad it has kept me up for 2 night and pain still present

I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anaphylactic shock, I broke out in hives, and my throat was closing

Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report

Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was examined in ER. CT of chest showed "questionable minimal small airway inflammation in upper lobes". Patient was discharged from ER home with Methocarbamol 750mg PO Q12 hours as needed.

During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.

Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.

5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction

Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given in ER triage. Caregiver given racemic Epi and another dose of IM Epi in ED. Further care please refer to ED MD

Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking

I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.

Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.

Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.

Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.

Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.

approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.

Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & felt "slow swelling" in her throat. Also reporting "slow swallowing sensation" Patient brought out to back triage area, vitals stable, NO SOB, no wheezing, no lip or tongue swelling noted. 167/95, 63, 99% RA. Reporting feeling anxious. Only allergy or similar event patient reports is medication, ephedrine during delivery which was treated w/ O2 during her delivery Repeat vitals 134/90, 59, 99% Allergy MD on call notified of event, per MD continue to monitor for additional 30 minutes and call back w/ any further symptoms 136/93, 60 & 99% After 30 minutes, patients vitals stable, sensation has resolved & felt well enough to go home 127/92, 59 & 99%

After receiving the second dose of the COVID vaccine the patient went home but returned to the ED the following day complaining of shortness of breath that feels like prior asthma attacks. She presented to the ED at 0833 short of breath with a dry cough and hoarse voice. She was given albuterol then monitored and re-evaluated at 0921. At that time the patient stated that she felt a little better, and declined any further evaluation since she reported that she felt the same as she always does while having an asthma attack. She states that she would not have come to the ER if she had not been at work and been required to. She was discharged with prednisone at 0923.

Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.

Patient returned 2 hrs after vaccination c/o shortness of breath and "tingling fingers." Hyperventilating upon arrival. VS - 1326 - BP 129/78, HR 90, 100%. 1331 - 131/68 - HR 80, 100%. 1337 - 126/71, 83, 100%. Code yellow called. Patient to ED.

As soon as patient received vaccination, her left arm became heavy, then she became dizzy with chest pain on deep inspiration. Initially became short of breath, which resolved prior to EMS arrival. EMS transported patient to the emergency room with non-urgent acuity.

chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable

Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Severe nausea/vomiting, SOB, throat swelling, dizziness, headache, chills. HRT recommended ED visit. She had IVF and Zofran. Symptoms improved.

Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.

10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began to close up and was given PO Benadryl - no relief. Required Epinephrine and transport to ER

20-30 minutes after vaccine patient returned to observation center complaining of difficulty breathing and constriction in throat. Vitals stable, pulse ox 100%, pharynx clear without edema and no wheezing. However she was quite distressed, becoming diphoretic, and stating that breathing and throat constriction was worsening. She was treated with 0.3 mg epinephrine IM left thigh and 25mg Benadryl left deltoid. After treatment breathing improved, throat constriction resolved, and she felt a rapid heart rate and dizziness. These also gradually improved and she was discharge home with her husband, with prescriptions for famotidine, loratadine, to not take metformin today, and strict ED precautions for recurrence of breathing or throat constriction symptoms.

I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).

Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.

Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly

15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and monitored. Continued to have itchy throat and some rash, felt like prior episodes of anaphylaxis, reported some sob though stable vital signs, sent to ED

Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92

Present to ER with SOB and coughing. Second COVID-19 vaccine was given at 10:30 am and she started feeling chills and cough about 2 hours later. Also, pt reported body aches and neck spasm. Patient given EpiPen as reports feels hard to breath, Solumedrol, Pepcid and Benadryl and reports sob resolved. Ptient watched for 2 hours, no return of symptoms, SOB resolved, and patient start eating and drinking and feeling well. discussed with patient use of Tylenol and Motrin for post vaccine aches and fever and follow up with employee health tomorrow. Patient discharge to home. Note: 1) patient doing well and get back to working the next morning (2/10/21) 2) Past medical history: Asthma and diabetes

Approximately 45 minutes after the vaccine began to have dizziness, increased anxiety, and wheezing. Progressed to difficulty breathing/shortness of air and unclear thinking. Related hypoxia occurred. Treated at home with antihistamines and albuterol. Epi-pen was not used, but should have been.

SEVERE ACHING IN MUSCLES AND JOINTS. FEVER UP TO 102 X 2 DAYS. POINT TENDERNESS TO ENTIRE BODY. COULD NOT WALK FOR 6 HOURS (MUSCLE WEAKNESS), CONFUSION, DIZZYNESS, HEADACHE, ABDOMINAL PAIN, CHEST PAIN, SHORTNESS OF BREATH.

Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat; sweating. She takes Allegra 180mg daily and took 12.5 mg Benadryl prior to injection. After symptoms began, she was treated with Pepcid 40 mg, Benadryl 25 mg, prednisone 40 mg. Symptoms of tachycardia and tightness in neck began almost immediately after injection. Other symptoms began 5-10 minutes later. Symptoms persisted in waxing/waning fashion for about 1.5 hours. Oxygen level remained at 100% on room air. Lungs were clear- no wheezing. She was observed for about three hours. Heart rate was in 80-90 range for the last 1.5 hours. She was released to home with husband. To continue prednisone 40 mg next three days, then taper off. Continue Pepcid 40 mg daily for 5 days. Benadryl 25 mg every 6 hours as needed for breakthrough symptoms. Continue her usual Allegra 180 mg daily. She has f/u on 2/15/21 or sooner if symptoms return and not controlled with above.

Within one minute of receiving the shot my throat felt like it was swelling and I had difficulty swallowing. Lasted about 30 minutes. Two days later my right leg felt dead and big, similar feeling to when I had a spinal for a cesarean section. The sensation was off and on for 2 days and then subsided.

Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better

Patient was vaccinated at 11:06 AM with Pfizer vaccine then headed out to the observation area to sit for 30 minutes. At approx 11:45 AM, Patient s/w observer medical staff and c/o throat tightness. She was then moved to another area for further assessment while 911 was called. Nurse and Dr. stayed with patient until paramedics arrived at approx 11:48 AM. Patient was triaged by Paramedics then transported to Emergency Department at 11:55 AM. Patient was assessed and found not to be having an adverse event but possibly anxiety expisode. Patient was released to go home at 12:55 PM.

Dose #2 pfizer; Pt reported onset of chest pain and SOB within 5 min of vaccine. Followed by nausea, vomiting, and feeling of swelling of lips, . Pt used her own albuterol, 2 puffs. RRT called. BP 166/99, HR 90, pulse ox 100, airway intact, lungs clear, cardio tachy but regular, skin warm and dry with no diaphoresis. Concern for anaphylaxis as pt symptoms continued and some increase in disorientation Epi Pen administered, O2 via NC. IV access attempted but unable to obtain. EMS called. Pt monitored with resolution of CP, SOB, nausea, lips swelling and disorientation. Pt continued to have feelings of swelling of tongue and transported to ED

EE reports getting her second Covid (Pfizer) vaccination at 11 AM on 02/16/2021. With having concerns of her throat feeling "hot" for about six hours after her first vaccination, EE pre-medicated with Allegra and Pepcid prior to the second vaccination. EE reports that within 20 minutes after the second vaccination her throat got hot and felt swollen, so she took Benadryl. Between 1900-1930 that same evening EE reports that her throat felt like it was tightening up, so she went to acute care. EE was given Solumedrol IM, Decadron orally, Benadryl 50 mg, and Pepcid. EE states that her HR was in the 140's, and she was flushed at this time.EE reports that she is now on a 10 days course of Prednisone, Zyrtec for 2 weeks, and Benadryl prn.

10 minutes after injection felt extreme dizziness to the point of feeling faint, tightness in throat, severe itchiness in throat, tongue, ears, mouth and all over my body, and felt nauseous. Had to be treated in Urgent Care for these symptoms, Benadryl was administered, and seemed to help the itchiness and tightness of throat

Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.

pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM

"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache

Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.

About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day

A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.

Patient became significantly SOB w/ increasing coughing and chest tightness. Patient also developed lightheadedness. She was transferred to a litter and had a pulse ox applied. She noted increased SOB after lying flat and was administered an Epi-pen and then placed in an upright seated position (supported). Symptoms did improve and she was also administered 4 puffs of her personal inhaler with additional improvement but not complete resolution. EMS was contacted and patient was evacuated to the ER for further evaluation and treatment. HR remained tachycardic and SPO2 98%.

This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm. Staff monitored her for 30 min due to past hx of "allergies" and 28 min post vaccine she c/o difficulty breathing in (described as sensation of heavy breathing/was taking deeper breaths than usual), a dry mouth/throat, and a very faint dull pain to her forehead. She denies any cp, mouth/throat swelling, angioedema, rash, myalgia, weakness, fever/chills, difficulty swallowing, no wheezing, cough or other systemic symptoms. Nurse came over and gave her epi pen at 1515 and sent to ER. In ER: VS 160/83, HR 103, Resp 28, O2 sats room air 100%, T98.9F. Lungs CTA in ER. Headache worsened, but no difficulty breathin

Patient complained of dizziness, coughing, and shortness of breath. She was alert, able to talk and was not wheezing. She was monitored for 30 minutes and symptoms subsided. Husband stated she has been coughing for a few days and was going to see her primary care doctor soon.

Around ten minutes post injection PT experienced tingling throughout body, slight constriction in throat, lungs clear throughout no wheezing, BP: 138/89, o2 saturation: 98%, HR: 89 PT then developed facial swelling , administered benedryl at 1815 PO, constriction continued as well as facial swelling post medication admin. PT declined Epi-Pen recommendation. At 1830 an addition PO administered, no change in PT condition. Decision to contact EMS at this point, Medic responded to the scene where patient was sent to hospital.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium

1/12 vaccination 6:30 I felt nauseous. Vertigo. Started to get chills and HA. Progressively got worse. 103 temp middle of night. Asthma was bothering me. Took my nebulizer, tylenol and motril. Called employee health; COVID test/negative, Symptoms lasted 2 days. PCP ONLINE; prescribed prednisone *Irritated my asthma for 2 weeks which was very unusual for me. Couldn't work because I couldn't breath with the 2 masks required. I would start to wheeze really bad just walking up flight of stairs.

Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.

Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin

Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.

Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.

Patient received her first dose of the Pfizer vaccine today. About five minutes after injection, patient developed shortness of breath and a burning chest pain. She was talking in complete sentences without any issues. She had no other symptoms. Call placed to 911. Her lungs were clear through out, her heart rate and rhythm was regular. See vitals below. A 20g IV was placed to her L AC and Benadryl 25 mg IVP, Solumedrol 125 mg IVP and Famotidine 20 mg IVP was given by the RN. Her shortness of breath improved, the burning to her chest persisted. EMS arrived at 0914 and she was transferred to the nearest hospital for further evaluation and treatment. Patient declined contacting any family members by the staff, she requested to call her husband herself. 03/17/21 0923 BP: (!) 162/70 Pulse: 110 Resp: 22 SpO2: 98%

After the first injection, I noticed mild mouth tingling, but nothing else, did not report as it was so mild and it was more notable in retrospect. A week after the first injection developed vertigo for the first time in my life. This lasted about a week had mostly resolved when I got the second dose. Immediately upon receiving the second dose I felt faint. I went to the observation area and when the feeling got stronger, reported it. My blood pressure was taken and although I always have normal blood pressure, it was extremely high - 195/100. My heart was racing. I was observed for longer because of this, and was asked to lie down. The faint feeling and high blood pressure lasted 30 min, at which time it started to improve and was sent home. I persisted in having bouts of feeling faint (but never fainting) in the days and weeks following, joined with shortness of breath which started the second day after the second injection. I also had the normal fever, aches and pains for 4 days. It is now a month after the second injection, and while the faintness and vertigo are mostly gone, I have persistent shortness of breath. Prior to the vaccine I had an albuterol inhaler that I would use 1-5 times a year for allergies. Almost never used it. I began having to use it multiple times daily after the second dose of the vaccine. I am not on a steroid inhaler. I have never had shortness of breath like this before. I was examined at the doctors office, not much can be seen that is wrong. An allergist believes that I did not have an allergy because my blood pressure was high instead of low as in anaphylaxis.

First shot - slightly tight feeling in my throat about an hour after shot, low grade fever second day Second shot - tight feeling in throat about an hour after shot for about 4 hours, and light headedness; fever later in day, fell asleep early slept 10 hours; second day ok in morning then fever getting higher all day but now better (6:30 pm so 33 hours after shot), extreme itchiness today day 2, like fleas - took Benadryl at noon and need more now; stomach ache and diarrhea.

Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium

Coughing, throat tightness. BP 155/124 (pulse 115), final BP 183/123 (pulse 96). Given EpiPen, sent to ED. At ED, received Benadryl 50 mg PO, Pepcid 40 mg PO, Decadron 8 mg PO. Resolved.

3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose appointment. Pt reported that she had a reaction w/ pfizer vaccine. Received Pfizer vaccine on 3/2/21. From review of available outside records, pt called PCP (outside provider) on 3/5/21 reporting itchiness, lip swelling, tongue felt enlarged but no trouble swallowing or SOB 2 days post-vaccine. Pt was advised to continue benadryl and if s/sxs worsen to go to ED. Per pt, they later developed SOB and went to outside ED where she received epi-pen and prescribed prednisone course. Pt followed up with PCP on 3/11/21 and pt report improvement in symptoms. Pt was advised by PCP not to get 2nd dose of pfizer.

20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage in my airways and could breathe easily through my nose, but did feel constricted in my throat for about 40 minutes.

Patient is a 43 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER8732 on 3/25/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:58am Patient vaccinated. 12:14pm Patient c/o difficulty breathing and shortness of breath at rest during observation period. Patient was treated/managed as follows: 12:15pm VS BP 142/72, HR 94, RR 20, O2 sat 96% on room air. Patient educated on breathing techniques. No swelling noted to mouth, tongue or throat. Patient reports symptoms slightly improving. 12:25pm VS BP 138/78, HR 85, RR 20, O2 sat 98% on room air. Patient reports feeling better and symptoms subsiding. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:33pm Patient escorted to car by site lead Parnesh and patients daughter.

5 minutes after injection started to feel dizzy. Not room spinning dizzy. More like a fogginess. Had a hard time comprehending. Trying to use my brain made the dizziness worse. Was unable to drive. 90 minutes after injection started feeling winded while laying down. Took 25mg of Benadryl at 2hr mark after injection.

Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.

Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue within 45 minutes

Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.

Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.

Patient seemed slightly apprehensive, but stable after 20 minute observation period following immunization with COVID19 vaccine at 6:55. Patient requested to leave the store to check her blood sugar in her car, but shortly returned after (approximately 5 minutes), feeling stuffy and reporting that she was experiencing shortness of breath/difficulty breathing to the front store manager. Patient appeared diaphoretic, tearful, and having trouble breathing. PharmD felt for patient's pulse; felt thready and hard to palpate. PharmD administered epinephrine 0.3 mg via Epic-Pen into patient's left thigh, laterally, at 6:03 pm. Patient still appeared unwell, though conscious and breathing - pulse was difficult to palpate. 911 dialed and EMTs arrived within 3 minutes and took patient to the nearest hospital. Patient's family was present and sharing medical history with EMTs.

43 year old female with a past medical history significant for asthma, anxiety, DM, migraines, thyroid papillary carcinoma who is presenting to the ED with an allergic reaction. She received her COVID vaccination at 1700. At approximately 1715 she felt a lump in her throat. Shortly after she felt as if her tongue/lips were tingling/becoming swollen and then she developed nausea. No rash or abdominal pain. No dyspnea or chest pain. All symptoms are consistent with prior episodes of anaphylaxis. She has had anaphylaxis to vaccinations in the past but was advised by her allergist to get the COVID vaccine today. On arrival patient is quite anxious. Vital signs are stable. Her tongue is enlarged/mildly edematous, additionally appreciated mild lip/perioral swelling. There is no stridor or wheezing, no evidence of respiratory distress. Given examination findings, symptom description, findings concerning for anaphylaxis. As such, epinephrine promptly administered as well as solumedrol, famotidine, and benadryl. Shortly after the epinephrine she endorsed improvement in her swelling, though during benadryl administration she endorsed a sudden onset of subjective throat swelling/felt as if she could not breathe. Patient was reassessed, no change in initial examination findings, within a few minutes she felt her symptoms improve without intervention.A short while later she again felt as if her throat swelling was worsening, as such epinephrine dose re administered. Following a 2.5 hour period of observation she endorsed continued improvement in her allergic symptoms, requested discharge home though continued observation offered. A course of prednisone prescribed, patient already with epi pen. Patient discharged home.

Patient arrived stable and afebrile; received first dose of Pfizer/BioNTech COVID19 vaccine, administered by pharmacist. During 15 minute monitoring period, patient and accompanying family reported to pharmacy team that she was feeling unwell and noticed some difficulty breathing. Temperature check revealed patient to still be afebrile. Pharmacist performed pulse check on left wrist - heart rate appeared even and steady; grip strength present. Patient denied any vision changes, but felt dizzy; difficulty in breathing remained stable and constant, not worsening nor improving. Pharmacist administered oral diphenhydramine 50 mg to patient, and technician dialed 911 to reach emergency services. Patient brought to front store with other pharmacist, where vitals taken and additional care provided.

Chest pain and pressure; Chest pain and pressure; Unable to gasp air and hard time breathing; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 22Feb2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient had no known allergies. Concomitant medication included methotrexate from an unknown date at an unknown dose, for an unknown indication. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Lot number unknown) on 03Feb2021 at 15:00 (at the age of 43-years-old) via an unspecified route of administration in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 04:00 the patient experienced chest pain and pressure, the patient was unable to gasp air and hard time breathing. The events were reported as non-serious. The patient did not receive treatment for the events. The clinical outcome of the events chest pain and pressure and unable to gasp air and hard time breathing was recovering. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Asthma symptoms were markedly worse on the 2nd day after injection. I needed to use my rescue inhaler throughout the day (this is not normal as my asthma is generally well-controlled)

Patient was a 43 yo F who presented to ED on 12/25/2020 with complaints of worsening shortness of breath for past 3-4 days. The patient tested positive for COVID 12/16/2020 and her symptoms worsened three days prior to admission. Patient was diagnosed with COVID infection with acute respiratory failure with hypoxia. She was treated with dexamethasone 6 mg once daily for 3 days, Tussionex 5ml q12h prn for cough for 2 days. Patient was discharged home on 12/30/2020 with improved SpO2 and a discharge medication list of dexamethasone 6mg daily for 7 days, benzonatate 200 mg one capsule by mouth TID prn, guaifenesin ER 600 mg, Tussionex 10-8 mg/5ml, and Vitamin D 2000U.

Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. Eyes and throat began swelling. Doctor told me to use the epipen on myself since I was salivating a lot. Called the ambulance and was taken to Hospital. Doctor told me that they thought the Lisinopril allergic reaction was activated. It is now Sunday (four days later) and I am experiencing muscle aches in my right arm and nerve pain in my right hand/fingertips. On Saturday, my right arm was twitching and cramping. Felt chills on Friday.

Tickle in throat, cough, throat clearing started approximately 10 minutes after injection. After about 40 minutes of these symptoms , received Benadryl 50 mg po, symptoms continued, tachycardia and tachypnea developed and worsened to near continuous cough, hoarseness/laryngitis, tachypnea, tachycardia, nausea, dry heaves, difficulty swallowing, trouble catching breath over next 30 minutes or so. Received solumedrol 125 mg IV, epinephrine im x2, Pepcid IV, racemic epinephrine neb, epinephrine gtt starting at 0.05 mcg/kg/min. After 2nd IM epinephrine, symptoms slightly improved. After approximately 1h on gtt, was able to be decreased to 0.02 mcg/kg/min and then turned off after another 30-60 min.

Swelling of tongue and throat. BP 209/115 (pulse 104). Given Epi-Pen, then sent to hospital. Was at hospital for 1 day, and received IV Solumedrol, Pepcid, IV Benadryl.

Approximately 5 minutes post vaccination at the county public health center drive through vaccine clinic while patient was in the observation parking area the patient beeped her horn and indicated to staff she did not feel well. She had flushing of skin of the chest, and a cough that was just starting. EMS was called at 12:07 PM, and per standing order RN administered 50 mg of Benadryl intramuscularly in the right deltoid at 12:08 PM. The patient progressed to persistent coughing, wheezing, and difficulty talking stating she felt like a lump in her throat and tightening in her throat. Again, following standing order RN administered 0.3 mg of Epinephrine in the left thigh intramuscularly at 12:14 PM. EMS arrived by ambulance at 12:17 PM. Patient was stable upon EMS arrival with all signs/symptoms of allergic anaphylactic reaction gone. EMS evaluated patient and patient signed declination to go to the hospital for evaluation. She remained on site until 12:41 PM when her father / mother came to pick her up from the vaccine clinic site. Follow up was done with patient on 04-21-2021 @ 11:30 AM. She states that no further reaction occurred, and she took no further medications.

pt reports she became itchy and noticed red bumps on arm then went into rest room and saw it was all over her whole body she returned to her car where her husband was during trip home she developed headache and began having difficulty breathing they went to hospital where she reports she spent two days received two doses of epinephrine and three doses benydryl she reports she would have flare ups of the rash during hospitalization

Was taken to the ER due to chest pains and shortness of breath. Was diagnosed with having a Spontaneous Coronary Artery Dissection occurred on April 15, 2021.

Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium

high blood pressure/blood pressure 167/93/Blood pressure 144/95; Racing pulse/pulse was 177/pulse was 163/Pulse 116/ rapid pulse; Her heart was pounding; she couldn't catch her breath; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8983, Expiration date: Unknown), via an unspecified route of administration in left arm on 01Feb2021 at 08:45 AM (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history included mitral valve prolapse (diagnosed at the age of 18). No known allergies. Concomitant medication included medroxyprogesterone acetate (DEPO PROVERA) from an unspecified date in 2020 and ongoing, received in two weeks within the vaccination. She took a Depo Provera shot on Saturday 30Jan2021, but she has been on this medication for a year now since either Feb2020 or Mar2020. The lot number and expiration date was unknown, since she has discarded the packaging. She usually picks up the drug, and her neighbour was a nurse, she usually just gives her the injection, since COVID has started. The patient previously received flu vaccine on an unspecified date in 2020 for immunisation and experienced feeling bad, didn't feel good. The patient previously received flu vaccine on an unspecified date for immunisation and experienced thrown up, chills, fever, body was sensitive. Caller was queried she if she had had any issues with vaccine in the past, caller states that she takes the flu vaccine every year, her body was sensitive to the flu vaccine, this year she had no issue, but last year (on an unspecified date in 2020) after the flu vaccine she started feeling bad, didn't feel good, years before she has thrown up and had chills and fever. Her body must be sensitive. However she has never had the heart issues. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested with COVID-19 post vaccination. It was reported that, she was calling about the COVID-19 vaccine. She received the vaccine yesterday at 8:45 AM, then at 12:30 PM she began to have a rapid pulse and high blood pressure. She went to the ER because of her pulse and blood pressure. In the ER, she received an IV to calm the heart, she doesn't know what was in the IV. They did blood work and told her the blood work was fine, and the chest X-ray was fine. She went to a Cardiologist today, she does have a valve prolapse, but she has had no issues with that for many years. She states that her body had a weird response to the covid vaccine. Caller states that she need Pfizer to know what happened because it was real scary. She has her first dose on 01Feb2021 at 8:45 AM. The rapid pulse began while she was sitting at the computer working. Her heart was pounding on 01Feb2021, she couldn't catch her breath on 01Feb2021, and so she was a school teacher, so then she went to find the nurse, and even in that she was having trouble catching her breath to be able to even talk. The nurse took her into the office, and she put a pulse ox monitor on her finger. At 12:25 PM her pulse was 177, at 12:30 PM her pulse was 163 with blood pressure 167/93, at 12:40 PM pulse 116, blood pressure 144/95. The nurse then called the ambulance because it was alarming. Caller states that doesn't know what her readings were in the ambulance. She went to the ER at (institute name withheld) and they did an EKG, 2 of them. The regular ER doctor was not super helpful, he said that she was okay to take the second vaccine. Caller did not agree with him thinking that the 1st covid vaccine sent her to the ER. HCP: He was at (institute name withheld) Cardiology. He did an EKG today (on an unspecified date in Feb2021), she doesn't know results at the moment. He didn't say if it was normal or abnormal. They did an echocardiogram, she was also assuming nothing was alarming or she would have been told the results. He listened to the heart and said it sounded fine, there was nothing he could detect. She did have a rapid heart rate at the cardiologist office, both pulse and blood pressure were elevated. He said that she was going to do a stress test in a week, the doctor was also going to see what the blood work from the ER yesterday looks like, he would also check the thyroid. He told her that next week she would also wear a heart monitor. She was at the doctor's office today at 10:30 AM. Her biggest concern was which she talked to the cardiologist today about was the 2nd dose of the vaccine. She doesn't want a repeat of this event. The cardiologist said that she was supposed to get the second dose in 3 weeks, let's do testing and see where we stand. Her 2nd dose was scheduled for 22Feb2021. She was concerned this happened. She doesn't know what could be done. This was bizarre. In the ER, the doctor said this wouldn't be considered an allergic reaction. Caller wonders what this was considered then. The ER doctors thing was that this didn't happen in first 15 to 30 minutes of receiving the vaccine, and that would be considered an allergic reaction if it did. She wants to know if this was an allergic reaction. Enquired was this allergic reaction. The adverse events resulted in emergency room/department or urgent care. She has no results for the tests that were performed at the ER, she was just told the chest X-ray was normal and so was the blood work, but she doesn't know what the blood work involved. They were looking for blood clots at the ER. She was not admitted into the hospital, she was sent home the same day. She has had no positive COVID test prior to the vaccine. She also has had no symptoms, and therefore no reason to get tested either. On 01Feb2021, the patient underwent lab tests and procedure which included chest X-ray: Normal, pulse rapid: 177 (at 12:25 PM), pulse rapid: 163 (at 12:30 PM), blood pressure: 167/93 (at 12:30 PM), pulse rapid: 116 (at 12:40 PM), blood pressure: 144/95 (at 12:40 PM). On an unspecified date in Feb2021, the patient underwent lab tests and procedures which included blood work: Unknown results (the doctor was also going to see what the blood work from the ER yesterday looks like. They were looking for blood clots at the ER), EKG: Unknown results, EKG: Unknown results, Echocardiogram: Unknown results. The patient was treated with IV for the adverse events. The outcome of the events she couldn't catch her breath, her heart was pounding was unknown and not recovered for the other events.

breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged slightly; fluid built up around heart and lungs; fluid built up around heart and lungs; white blood count was elevated; heart was weak and only working at 29% percent; heart was weak and only working at 29% percent; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Feb2021 at 18:00 (at the age of 43 years old) (Lot Number: EM9809, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient also received first dose of BNT162B2 on 23Jan2021 at 18:00 (at the age of 43 years old) (lot number: EL3247, unknown expiration) in left arm for COVID-19 immunization. After the second shot, the patient did notice swollen lymph nodes on 02Apr2021 for several days. She noticed her breathing labored while walking or doing activity on 02Apr2021 after getting the second shot. In 8 weeks, the patient went to the ER and found that she had fluid built up around heart and lungs which started on 02Apr2021. They also found in a CT scan that lymph nodes were enlarged slightly and that the patient's white blood count was elevated on 02Apr2021. After an echocardiogram on 02Apr2021, they determined that the patient's heart was weak and only working at 29% percent. The patient has had no prior history of heart problems or was taking any medications. The patient was given many heart medications to strengthen the heart and treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID and was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab on 10Apr2021 with negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. The events were assessed as serious (hospitalization) for 8 days. No follow-up attempts are needed. No further information is expected.

Shortness of breath and pain in left abdomen. CT scan on 3/27/21 showed the following: Bilateral segmental pulmonary emboli. Findings were communicated to P.A., by telephone by Dr. on 3/27/2021 at 1:40 PM. At the request of the ordering provider, the patient was instructed to go to the emergency department for further evaluation and treatment. I, (name) MD, have reviewed the images and verify the above interpretation on 3/27/2021 2:12 PM. Electronically signed by (name) , MD on 3/27/2021 2:12 PM My treatment was to get on Eliquis, a blood thinner.

Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG and CXR were normal in ED and she was given albuterol, decadron, famotodine, and epinephrine and resolved.

Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen

slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.

Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.

Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.

Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020.

Following administration of COVID19 vaccine (Pfizer), patient experienced a "scratchy feeling" in her throat and feeling that her throat might be closing up. She denied any other symptom. Patient had no history of anaphylaxis. Patient was monitored until symptoms resolved. No treatment was required. Note: Patient received second dose of vaccine (from same lot# EH9899) on 1/6/21 and no adverse reactions were observed after 30 minutes monitoring. Patient reports that she felt much less anxious when receiving the second dose of vaccine.

difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered. Information on lot/batch number has been requested.

Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours

First Day after the injection I had a headache and nausea the entire day into the next day. The second day I still had the headache and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I struggled to breath. I immediately drank liquid Benadryl and called my doctor in the morning.

Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.

Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and my throat felt a little tight. Then, I started to feel kind of lightheaded and my legs were weak. I let the staff know and they offered me benadryl but I declined. I waited about 35 minutes then I went home. I continued to feel lightheaded and weak for about 4 hours and I also began to fill nauseous. My arm continued to be sore for a few days and I ran a fever of around 100 from the following day 1/9 and I am still running a fever now on 1/12.

10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.

Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.

throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer EL 3302), via an unspecified route of administration on 09Jan2021 07:30 am at single dose at left arm for covid-19 immunization. Medical history included diabetes, high blood pressure, allergies. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 10Jan2021 14:30, patient woke up with throat closing up and struggled the breath. Patient immediately drank a dose of diphenhydramine hydrochloride (BENADRYL). Patient did that two more time in the evening of 10Jan2021. Patient called the doctor in the morning. Events were considered serious per life-threatening. The adverse events resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient received treatment liquid diphenhydramine hydrochloride, epinephrine (EPI-PEN) for events. Outcome of events was recovered in Jan2021.

After the administration of the COVID-19 vaccine, during the observation period, the patient showed a swollen tongue and shortness of breath

2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.

I developed itching, throat itching, cough with wheezing and hives on my left arm. Elevated BP 197/94 Pulse ox was good.

Started having Covid-like symptoms, mainly cough and shortness of breath along with fatigue. Ran a low-grade fever for two days. Cough progressed and worsened and by the third day of symptoms I was bound to bed. Each time I moved, I couldn't breathe and coughed excessively.

approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot ek9231) on 08Jan2021 03.00 pm intramuscular in the left arm for COVID-19 immunization. Medical history included RA, spondylitis, GERD, known allergies to sulfa, penicillin, cefalexin monohydrate (KEFLEX), sulfamethoxazole, trimethoprim (BACTRIM), adalimumab (HUMIRA), ankylosis. Concomitant medications included acetylsalicylic acid (ASPIRIN), omeprazole, loratadine (CLARITIN) and infliximab (RENFLEXIS). First dose of BNT162B2 was administered on 21Dec2020 11:00 am (lot ek5730) intramuscular in the left arm for COVID-19 immunization. Approx 34 hours after vaccine (also reported as 03Jan2021) awoke unable to breath. Symptoms consistent with laryngospasm, symptoms lasted approx 2 minutes. No treatment provided. No COVID test performed prior or after vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of unable to breath/ Laryngospasm cannot be excluded, considering the plausible temporal relationship. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of allergic reaction to vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.

Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.

Chest tightness, shortness of breath, cough. Symptoms resolved with breathing tx in ER. Recovered from covid several months ago.

Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, some SOB, received epi, then started to break out. Prepare to take to BMC. Another dose of epi was given prior to transport. BP 176/106 HR 84 P 22

10 mins after first dose, pt reports feeling lightheaded, dizzy, SOB, and chest tightness. Pt denies numbness/tingling, sore throat, throat swelling, hives or fever. SBPs around 150s (normally in the 90s). Feels like she is going to pass out. Symptoms resolved and pt discharged at 2325.

About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest, I became nauseous, then developed rapid palpitations. I BP was checked about 10 min later and I was hypertensive SBP 180s. By the HR was down to about 90 bpm and I felt the palpitations begin to decrease. I was feeling better by about 10 min later and went home. I also had itchiness of the L hand for about 1 hr afterwards.

Patient stated "throat feels funny" and felt generalized flushing. Treated with benadryl 25 mg PO and observed 30 minutes with improvement of symptoms.

After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later patient was C/O tight throat, Solumedrol 60mg IM administered to Rt buttocks by this nurse. Pt then escorted to ER for further evaluation. On 1/25/21 at 1359: Patient reported tingling of lips and throat felt tight. SPO2 via finger with a result of 99%. Emergency room provider's note: 44-year-old female patient presents ED after allergic reaction. Patient received her first COVID-19 vaccination and during the 15-minute observation period began to feel as if she had some tightness in her throat and difficulty swallowing. She has a scratchy sensation to her posterior pharynx. She denies specifically shortness of breath, nausea vomiting, dizziness or near syncope. She was medicated with 50 mg of Benadryl p.o. as well as 60 mg of Solu-Medrol IM prior to arrival. She states she has never previously had allergic reactions to vaccinations in the past

Shortness of breath 1/26/21 @7:30am Headache 1/26/21 @ 11:15am Fever 1/26/21 @11:30 98.9 ° Fever 1/26/21 @12:30pm 99.5°

Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.

I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; feeling nausea; my legs were weak; my throat got tight; This is a spontaneous report from a contactable HCP. This 44-year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm at single dose for COVID-19 immunization on 08Jan2021 05:30 PM. Relevant medical history included osteoporosis and menopause. Known allergies included: soy, dairy, all nuts, sunflower, cottonwood, lentils, chickpeas, Vit E, cephalexin, Amoxicillin, sulfa, Bactrim, lisinopril , estrogen, moxifloxacin, Pseudoephedrine, paroxetine, trimethoprim, doxycycline, azithromycin, cipro, clindamycin, colestipol. The patient was not pregnant. Relevant concomitant drug included Vit D, calcium, ibuprofen. Five minutes after receiving the vaccine, her throat got tight then she started to feel lightheaded and her legs were weak. She notified the staff there who offered her Benadryl but she declined. She began feeling nausea about an hour later and she felt lightheaded and weak for about 4 hours. She started running a mild fever the next day and she still had a fever on 12Jan2021. The patient did not receive other vaccine in four weeks. The outcome of events was recovering. No treatment was received. The patient was not COVID infected prior vaccination. The patient did not have COVID tested post vaccination.

Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.

Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG. Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021

1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash on face, watery stools, 1/29--rash has resolved with benadryl, still severe diarrhea

This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of bnt162b2 ( COVID-19 VACCINE; lot EK9231, expiration date unspecified), via an unspecified route of administration on 08Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mild sleep apnea. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. On 09Jan2021, the patient experienced injection site pain and arm soreness on day 1 and day 2, patient was also very tired on day 1. Patient also had occasional sneezing and mild headache since day 1. On day 2, energy level was back to normal. However, on 11Jan2021, on day 3, the patient started to develop occasional shortness of breath and continued today, day 7. The shortness of breath comes and goes. On 14Jan2021, on day 6, the patient experienced occasional coughing and continued today, day 7. Since the patient was working in a pharmacy, she cannot rule out if symptoms were from vaccine or Covid exposure, so patient decided to get Covid test done today, day 7. The patient had no treatment received for the events. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Patient had no Covid prior vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with pending results on 14Jan2021. Outcome of events was not recovered.

Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced shortness of breath, headache, and fatigue for 2 weeks after vaccination. A day after vaccine, reports multiple episodes of subjectively bloody diarrhea. An evaluation by GI showed now abnormal findings. Patient tested for COVID and was negative. Advised not to get second dose of vaccine.

Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled a bit and I became sweaty. Nurse checked my blood pressure and it was very high for me (144/83) usually 117/78. Nurse administered one Benadryl tablet and I felt better within about 15 minutes. Now I just feel very tired.

During monitoring period post Pfizer COVID-19 vaccine, pt experienced throat tightness and left arm itching. Patient reported she had a slight headache prior to administration of Covid vaccine. Patient denied allergic reaction symptoms prior to leaving the COVID vaccine clinic.

No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the throat, ears, and armpits. She developed three hives on her abdomen. She took diphenhydramine and Claritin then was able to go back to bed. She did not use the EpiPen but had it available. When she woke up in the morning she had swelling of the eyelids and face.

10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.

Patient with throat tightness during monitoring period and left arm itching. Patient denied allergic reaction symptoms prior to leaving the COVID vaccine clinic.

Patient described arm pain at the site of injection soon after injection. Began to develop difficulty swallowing, which the patient described as her tongue feeling heavy and her throat feeling tight. Adult EpiPen was administered at 10:33 AM with PO diphenhydramine 25 mg immediately after. Symptoms resolved. Patient was tachycardic (~100) and hypertensive 140/100. EMS arrived and brought patient to emergency department for additional testing/monitoring.

after the fist shot i felt a bit out of breath and i had a bit of achiness in between my shoulder blades which i didn't think anything of because of Christmas and all then after my 2nd shot i felt more out of breath and my chest and throat felt achy if i pressed down on it

It began with right arm soreness and progressed to aches and low grade fever within the first 24 hours. Then it moved on to mid-sternal chest pain that radiated to my back and I had shortness of breath that increased with deep breathing after about 48 hours.

Fever; Chills; Joint pain; Headache; Body Aches; Swelling of the Throat; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Ulcerative colitis, no Known allergies. No concomitant medication. The patient previously took the first dose of bnt162b2 in right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. No Other medications in two weeks. On 19Jan2021 08:00, the patient experienced Fever, Chills, Body Aches, Joint pain, Headache and Swelling of the throat. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. Information on lot/batch cannot be obtained.

She received the first dose of the Pfizer Covid Vaccine in the left deltoid. She has reported allergies to oxycodone, codeine sulfate, and penicillins which she reports as experiencing hives. 1220 she reported itching at the injection site. 1224 she reported that her throat felt like it was itching, and she was assessed, O2 100%, BP 115/83 in the left arm. 126 she reported that she felt as though her throat was closing up ans she was given Benadryl IM 25mg in the right deltoid. 1228 she utilized her personal albuterol inhaler. 1233 EMS called to the building. 1235 she received EpiPen injection in left thigh. 1250 she was transported off the property by EMS.

Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was administered and rapid response called. Patient was transported to the ed . Per providers note, developed sensation of Facial swelling, lip swelling, tongue swelling and difficulty breathing

At 9:05 am client states she felt shortness of breath and her heart racing. Vital signs obtained by EMS, BP 135/83, pulse 90, Report O2 sat 99%, pulse 92. Client states she is feeling better. EMS discharge client. Client left vaccine site at 9:10 am.

I received the second dose of my vaccine yesterday morning. I waited 15 minutes and then left to go home. It took me 25 minutes to get home. As soon as I walked in the door, I noticed itching all over my body. I looked in the mirror and noticed a red rash with some hives, that covered my throat and chest area. My eyes were itching as well. I have had severe anaphylactic reactions in the past that required several hours in the emergency room, so I knew to take an antihistamine right away. The rash took at least a couple of hours to fade away; however, the itching of the eyes and body lasted until this morning. I did experience some occasional wheezing until 3 or 4 this morning. I am okay now.

ASMA TARQUICARDIA,PAIN ON INJECTION SITE,HEADACHE,CHILLS,FEVER,SICKNESS,ALERGIC ACTIVE PAIN ON CHEST AND REFLUX 2 DAYS OF SINTOMES.

Tingly sensation in both arms and slow and heavy breathing. Mask and morning exertion could have been a cause of the slow and heavy breathing. Tingly sensation went away quickly. The breathing issues resolved after inhaler was used and the patient drank some water.

Within 45 minutes, had an overwhelming metallic taste in mouth. Lost ability to taste food for 36 hours. Also had a fuzzy feeling in ears. Next day had fatigue, headache, aches, shortness of breath. Subsided within 48 hours.

Pt felt that heart was racing and some shortness of breath. @ 1328 HR 118, BP 132/98. Recheck @ 1352 HR 75, BP 130/98, RR 24. Pt feels recovered after resting and feels alright to drive home.

PAIN IN JOINTS STARTED 21 HRS AFTER 2ND VACCINE SHOT TOOK ADVIL; SHORTNESS OF BREATH/DIFFICULTY BREATHING. 48 HRS LATER HAD ANOTHER SLIGHT EPIDODE OF SHORTNESS OF BREATH

awoke on 2-17-2021 at approximately 11:55pm with SOB and chest pain-prior to these symptoms had body aches, sore throat, fever (100.3-101), chills approximately 5 hours vaccination

1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.

Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain

Patient reported on 2/9 that she started having shortness of breath, rapid HR, itchy skin, hand and feet redness. Her endo specialist advised her to take Claritin gel caps for 3 days. The reaction lasted 2 days and was advised not to take the 2nd shot.

First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallow Shortness of breath Rapid heartbeat (130) Paramedics took vitals blood pressure and heart rate. I was asked to lay on gurney which I refused. I sat in chair. Paramedics monitored for 45 minutes until everything returned to normal. Walked to car by paramedics. Mom needed to drive home I was unable to.

The patient experienced symptoms of throat swelling. These symptoms were Severe and were treated with epinephrine 0.3mg x 2 doses (1 in left upper arm and 1 in left thigh) and 50mg PO benadryl. The patient was discharged to ER after close observation for 20 minutes in improving condition.

Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.

Tested for SARS COV-2 on 3/1/21 prior to travel, asymptomatic at the time of test. On 3/1/21, after the test, she began having nasal congestion, body aches, achey at the base of her lungs and intermittent loss of taste. PCR test resulted evening of 3/1/21 was positive.

Dizzy, difficulty standing and walking, throat felt tight, breathing slowed down, trouble transferring thoughts to words

2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse. She is able to breathe without difficulty. She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine. She will call Dr. back later and may need note for work. 2/26 11:30 AM Received text message from patient. "I woke up with trouble breathing, hives on my neck and jaw and swollen face. Nausea and diarrhea. Trouble swallowing so I took Benadryl. Swelling went down on face but still tight in throat. . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday. I asked her if her symptoms were not changed, worse, or improved. She answered: "They got worse this am from 5 to 10 and feeling better now. As far as swelling and breathing feels better. 3/1 10:21 AM Dr. Spoke with patient 10:21 am. She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness. She does still have nausea, with occasional vomiting, and diarrhea. She felt well enough to return to work today. 3/3 11:09 AM Dr. spoke with patient. She stated that she is finally feeling "back to normal". We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination. She stated that at one point she was "close to going to the ER".

Asthma Attack 5 and a half hours after vaccine. Wheezing and tightness. Took Bendadryl and used inhailers and asthma attack stopped.

Tightness in throat; BPs 152/99 (pulse 120), 138/89 (pulse 105). O2 sats 98%, 96%. History of anxiety.

Intestines froze up, can?t breathe normally and my tumor and abdomen has been inflamed. My spouse also got a shot and has been projectile vomiting and has flu like symptoms. Both of us are lethargic.

Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat with some difficulty swallowing. No difficulty breathing, no wheezing, etc. Symptoms quickly lessened in intensity with first set of vitals. Injection was given at 1443. I have observed patient from immunization given through 1605. Treatment/intervention 1500: BP 138/90 Pulse 94 SPO2 98% Respirations 20 Diphenhydramine 25 mg given - patient requests to receive. 1502: BP 128/90 Pulse 100 SPO2 96% 1506: BP 126/88 Pulse 96 SPO2 99% Respirations 16 Patient tolerated 8 oz water, swallowing Without difficulty, still feels strange feeling in throat but much improved. 1510: Patient states she is feeling "much better" and has called spouse for ride home. 1525: 2nd dose of Benadryl 25 mg given. Patient is feeling much better, throat swelling sensation decreased, face is pink, not flushed, swallowing well and tolerated second 8 oz water. Instructed to contact physician regarding reaction today. Instructed to call 911 if any symptoms recur, difficulties breathing, etc. 1605: Escorted to husbands car, states feels "good."

Pt drove up post vaccine to observation lot. Pt stated " I feel short of breath and heart racing". EMT(on site) was called, Hr-88, o2-97% RA. Respiratory rate WNL. Pt kept for observation for 30 minutes. Pt discharged at 3:50 pm. EMT follow up with patient before discharge.

After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I felt nauseated. My BP went up to 150 and staff was monitoring me, my normal BP is 90/110. After two hours I started to feel dizzy, nauseated and i was in the ER room for four hours. I felt like passing out, my BP was 169/69 and my heart rate was also high. Then I started to feel cold and began to shivering while an EKG was performed. My BP never went down. After one week and for four days I had fever and weakness to my body also from my knees down felt weakness. Also one week after my vaccine, my lymph nodes got swollen, left ear. I communicated these symptoms to my PCP of my reactions.

flair up of asthmatic bronchospasm; used albuterol sulfate hfa inhalation aerosol inhaler and took 20 mg of prednisone

Within a minute of getting the vaccine, my throat closed off. I could still breathe, but it was hard. I also felt a strange sensation in my chest (this latter sensation I only remember feeling twice). The difficulty breathing came and went for about 15-30 minutes. The EMS was called, and they took my blood pressure, blood oxygen level, and listened to my lungs, heart, and throat. They said they sounded normal. After this, I waited at a parking lot for another 15-20 minutes. I felt a bit strange, but I could breathe better. They did not inject the EPI Pen.

SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene transferred to Emergency room via ambulance C/) SOB, itching and swelling at the back of her throat and in her neck. No hives. No syncope. Described as moderate and later mild. No radiation, no vomiting, no wheezing. Patient discharged from ED at 09:30 am

Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.

Fever achey bones muscles hard to breathe sever shape / acute head pain. Whole body aches pain chills couldn?t stay awake had to sleep continued through sunday at time of report with only some relief was told to rest and take Advil by pcp

Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of cotton. My lips swelled. This happened within a few minutes of getting the vaccine. I was already being observed in a 30 minute seat, 20-30 minutes were added and three different professionals addressed the issue including a nurse practitioner. About 20 minutes after leaving the facility, about 1.5-2 hours after getting the vaccine, I noticed I was easier to breathe and I hadn?t realized how much my tongue and inside of mouth had been swollen previously. After these 2 hours, I felt fine. The following day I experienced a headache and was tired. Otherwise was fine.

Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and throat as symptoms progressed.

I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested diagnosed with pneumonia was prescribed two inhalers. On week three started running fever even after two antibiotics.Im recovering still exp shortness of breath at times.

Started feeling severe body aches and chills about 15 hours after 2nd dose vaccine. Symptoms improved and only lasted around 24 hours. Felt fatigue about 24 hours later and started having trouble breathing at around 48hours. Went to urgent care and was told to go back on my albuterol inhaler. Felt better the next day. No other symptoms since then.

Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and about 15 minutes into my drive I began feeling very funny in my head, my heart rate went sky high, started shaking all over my body. Could barely drive called 911. Was advised to pull over and await for ambulance. Ended up at ER with elevated heart rate, chest pain and feeling winded. I could breath ok no swelling in throat but just felt like a elephant was on my chest

Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and enter my nasal cavity. At which time it seemed to dry up what ever nasal mucus I had. Almost immediately I felt dizzy and light headed. Then came the my heart beating faster. My breathing quickened cold sweats began with the palms of my hands. This continued for about 3-4 minutes. When my heart/ blood pressure seemed to go back to normal, I sat for an additional 15 minutes. I had 3 more incidents that day of dizzy and lightheadness throughout the day but not to the extent of the initial, almost passing out, spell. For 12 hours after injection, other than the typical reported symptoms of sore arm, fatigue which I did experience, i felt like I was in a haze, similar to when you have a fever for 11 hours. And oddly, almost immediately the haze and fatigue lifted. No other adverse reactions after that.

5 days after receiving the vaccine I began to wheeze. I've never had a problem with wheezing before. This has continued and I had to be prescribed an albuterol inhaler.

Hives, itchy, throat tightness. Given epinephrine and Benadryl by EMS at scene and transported to hospital for evaluation.

Patient received 2nd dose of Pfizer vaccine on 3.21.2021. 4 minutes after receiving the vaccine (1200), the patient came to the nurses station stating, "I feel like I'm going to pass out." Patient seated and given cool rag. Patient proceeded to feel difficulty breathing and itchy throat. Patient given 1 dose of epipen at 1205. Patient tolerated well. Patient states she is breathing easier at 1208. 1211, Patient drinking water, feels better. Pain 0/10. EMS called and transported to ER. Patient diagnosed with "vasovagal reaction" in ER. Physician noted that the patient has a history of panic attacks and that this incident felt similar to the patient. Patient has no difficulty swallowing, no ShOB, and/or swelling. Patient fully recovered from the reaction by the time she arrived to the emergency department. Patient discharged home with no restrictions.

12 minutes after receiving the vaccine my throat started feeling tight. I waited 1 minute to make sure it wasn?t going to go away. I motioned for the security officer to come over so I could tell him my throat felt tight, I was dizzy and lightheaded. He called for a nurse. Several people came over to check on me, take my vitals, ask questions and administer an EpiPen. They noticed I was very pale. I felt better for about 1 min but symptoms came back. An ambulance was dispatched. They came and took vitals as well. I was then loaded into the ambulance and transported to the hospital. Vitals were again taken. I was monitored and blood was drawn. Blood work came back that I had low potassium so I was given an infusion of that. I was sent home with a script for Famotidine 20mg, Fexofenadine 180mg and Klor-Con M20. Around 7:45pm I felt my throat tightening again so I took the 2 meds for the allergic reaction. Throat still feels tight at 8:57pm but not as bad as it did at 7:45pm.

Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had crawling sensation throughout body and throat felt a little tight/dry. The burning, itching and crawling feeling continued for a couple weeks. Had to take Allegra and Benadryl and currently am still taking it to ward of symptoms.

10 min. after pt. received the vaccine she began to wheeze. She used her own Albuterol MDI. There was no improvement. She repeated the MDI 5 min. later. Her chest got tighter and wheezing increased. Pt. taken to treatment room and 911 called . Pt. given 25mg Benadryl by MD who is on site at vaccine clinic. At 0955, pt. given 0.3ml epi. in right upper arm. At 9:57 pt administered 2 more puff of Albuterol. On exam: HR 92, BP 138/82. EMS arrived 10:10, IV access obtained, dexamethasone pushed, and albuterol neb started. On transfer BP 144/80, pulse 85 and o2 sat 100%. Pt. remained awake and alert. Wheezing improving on transport at 10:20. Notes provided by Dr.

Patient was extremely anxious prior to receiving Pfizer IM injection. Once she received the vaccination she reported that she was having ?trouble breathing?. She stated she has asthma and that she needed her inhaler. She pulled a benadryl from her pocket and took it. Patient denied feeling any swelling in her throat. Two nurses stayed with the patient until she stated she was feeling better. Nurse escorted the patient to the observation area. After sitting in the observation area for several minutes the patient had used her inhaler and stated that she felt like she was going to pass out. 911 was called, the patient was assisted to the floor, vitals were monitored BP 170/90 HR 148 R16; Spo2 100%. Both Nurses stayed with the patient until EMS arrived to educate relaxation techniques and deep breathing. Patient was taken to the hospital via ambulance. While waiting for EMS that patient had called her daughter and stated she was having a ?panic attack? her daughter stated ?what is wrong with you, you need to get help?. Patient reports having a long history with anxiety.

Pt brought into COVID clinic, with HX of anaphalaxis rxn to flu vaccine, bu pt requested to con't w/ COVID vaccine. Pt informed to wait after COVID vaccine for 30 minutes. Approximatly 20 minutes of waiting pt started to feel like throat was swelling and she was having difficulty swallowing. Pt taken to private area and vital signs (BP 143/106, HR 62, POX 97%RA) obtained by this RN. Pt was given oral Benadryl 50mg and oral Pepcid 20mg. Pt reports that she was feeling better after oral medication, but I asked her to wait till 11:00. At 11:00 pt was still feeling better, and almost s/sx free, but I asked that she wait longer. At about 11:10 she stated that she started feeling worse with regards to her throat, a and swallowing. At this time 11:15 I gave her 0.3ml of Epinephrine IM in her Rt shoulder, and 911 was called to transport to ED. VS (162/103, HR 82, POX 97% RA) At 11:20 EMS arrived and report was given to paramedics and pt transported to ED.

Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130/80. HR: 66. Pt appeared pale and gray. At 14:20. Epinephrine 0.3mg adm x 1 IM (L vastus Lateralis) by the RN. at 14:22, pt sts feeling better. At 14:25, pt sts throat feels as if closing and tongue swelling again. EMS has arrived at that time and pt agreed to be transported and they took over her care.

Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.

15 minutes after second vaccine patient complained of tongue swelling, throat closing, and difficulty breathing. She was then given epi times 1 and benadryl. Symptoms then improved. 20 minutes later symptoms returned and she was given another dose of epi. EMS then took patient to local hospital.

Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6199 and expiration date unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 as a single dose for COVID-19 immunization. Medical history included depression, pre-diabetes and known allergies: bee stings. Concomitant medications included loratadine (LORATADINE), metformin (METFORMIN), paroxetine (PAROXETINE), and bupropion hydrochloride (WELLBUTRIN), and "Mul". The patient had no other vaccine in four weeks. On 09Mar2021 at 15:15, The patient experienced dizziness, numb tongue, difficulty swallowing, difficulty breathing, and inability to move arms and legs. The patient had no COVID prior vaccination and had not tested post vaccination. Therapeutic measures were taken as a result of the events which included Epinephrine, ER treatment, and Prednisone. The outcome of the events was resolving. The events resulted in: Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).

I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had difficulty breathing for 2 weeks. I have had eye twitching in my left eye for 3 days. I have had tightness in my chest and tingling in my chest.

After 10 minutes of the injection, I started feeling a mild tightening in my throat. It still ongoing, after 2 hours of the injection. No other symptoms were observed. I'm breathing normally.

She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.

The first shot on March 6, 2021, I only felt muscle pain in my left arm unable to move it on the next day due to the injection. Nothing else. The second shot on March 27, 2021 I started with fever, chills, night sweats, stomach cramps, headache, sore throat, nausea, tiredness, shortness of breath, muscle pain, weakness, unable to concentrate or do my job.

3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.

I had an asthma attack at work. I felt nausea. I checked into a Medical Center ER when I was having the attack and I couldn't control my breathing body aches - and they gave me anti-nausea medicine. A few days after that I was non stop throwing up - I couldn't get out of bed. I was still having intermittent vomiting - about once a week - and I'd have to take off work. This kept happening up until about a month ago (with the vomiting). It was horrible. I had headaches, too - they weren't major but were bothersome - I had them for about three weeks and then they went away. A couple of weeks later - I was still throwing up and I went to ER - but I don't remember the date of second visit - they gave me IV and Zofran. I had stomach pain from the vomiting. I was admitted into hospital last week - the 18th and was discharged the next evening. I was using inhaler every day for two times a day. They dosed me with a lot of antibiotics - IV antibiotics and also Steroids - Zumatrol and they sent me home with doxycycline HIC 100 mg and those were for 10 days; twice a day; and I haven't been needing my inhaler since last Friday.

20 minutes after injection, started feeling itchy all over. Began coughing and having asthma, used inhaler twice with no relief, was taken from coliseum by ambulance to ER. Enroute given epinephrine and 50 ml of benadryl. At ER repeat epinephrine and benadryl, H1/H2 blockers given. Released after three hour observation. Diagnosis of anaphylaxis.

44yo F with PMH of anaphylaxis on multiple medications who developed subjective symptoms of her throat becoming tight, dry, and scratchy. Pt became tachypnic and tachycardia to 110s, 100% saturation. Pt was evaluated by medical staff and ems, given oral hydration and 60mg fexofenadine. Pt was monitored with symptomatic improvement after 45min. She was cleared and discharged with instruction to not recieve second pfizer dose.

EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself). A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA). The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB) after running outside around a lake. No previous history of anaphylaxis or allergies. Reports that she had her COVID-19 vaccine 1 week ago. and had question about if that could have contributed to the event.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient showed signs of anxiety starting before injection

dizzy; throat started to swell; Within five minutes of the immunization my heart was racing; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 18Dec2020 09:00 (at the age of 44-year-old) at single dose for COVID-19 immunization. Medical history included dairy allergy. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine nor any other medications the patient received within 2 weeks. Within five minutes of the immunization on 18Dec2020 the patient's heart was racing, she was dizzy, her throat started to swell, and she was brought to the ER where they gave her epinephrine and Benadryl. She was admitted to the hospital (Dec2020) two times within a week due to the same symptoms; continuous heart palpitations. She was still having heart palpitations. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for 5 days. Since the vaccination, has the patient been tested for COVID-19. Covid test was negative on unspecified date. The outcome of the event heart was racing was not recovered and the outcome of the remaining events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events palpitations, dizziness and pharyngeal swelling occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.

SOB, Wheezing, headache that started hours before arrival to ED. She has never had COPD or asthma exacerbation before

Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/throat tightness and shortness of breath. Within 5-10 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine

Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 (Batch/Lot Number: Ep-7534) as single dose for COVID-19 immunization. Medical history included seasonal allergy, asthma, and known allergies: penicillin. Concomitant medication included fexofenadine hydrochloride (ALLEGRA); montelukast sodium (SINGULAIR); amlodipine. all taken for an unspecified indication, start and stop date were not reported. The patient previously took grastek for immunomodulatory therapy and experienced drug allergy; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En-6198) on 27Feb2021 for COVID-19 immunization. On unspecified date the patient experienced itching all over, coughing, asthma, anaphylaxis. The patient received 2 doses of epinephrine, 100 ml benedryl, and h1h2 bloc. The outcome of the events was recovering. The patient was not tested post vaccination and did not has COVID prior to vaccination.

felt like she was going to die; got really sick, a mess; can't breathe; chills but no fever; body really sore; head hurt every day; nose running really really bad but at first it was dry; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose in left arm for COVID-19 immunisation at the age of 44-year-old. Lot number was ER8733. Medical history included diabetes, Covid-19 in 2020. Concomitant medications included metformin for diabetes from 2019 and ongoing, insulin lispro (HUMALOG) for diabetes from 2019 and ongoing, insulin detemir (LEVEMIR) for diabetes from 2019 and ongoing. On 13Apr2021, patient felt like she was going to die, she could not breath. On 06Apr2021, the patient experienced got really sick, a mess, could not breath, chills but no fever, body really sore, head hurt every day, nose running really bad but at first it was dry. Since then, the patient has been very sick, like really sick, could not even be out of bed until the day before the report and the day of report she felt a little bit better. The patient has been drinking a lot of lemon juice; she also has been taking guaifenesin chest and runny nose congestion, guaifenesin Sinus Extra and acetaminophen. The husband of the patient got sick on Thursday or Friday; it was raining he got wet, so he was coughing; they have 3 kids, and the little one got sick same day as her. The patient did not recover from headache; the outcome of felt like she was going to die was unknown; the patient was recovering from other events. Patient stated that she was not saying it was because of the shot, but it was really confusing, she might get sick because her husband got sick for a few days and was outside working and it was raining and really really cold.

I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)

Pt with sudden fatigue, tiredness, scratchy throat and shortness of breath with in 2 hr of taking vaccine and lasting 3 weeks with only slow improvement

Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)

Patient developed adverse reaction like fever, flu like symptoms and rashes on the first day post vaccine second dose (05/01/2021) and then she went to ER morning of 05/04/2021 at about 1 am due to chest pain and SOB

Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an Allegra and went to the vaccination center. The Head nurse sent me to the Urgent care. During the exam I developed tightness in chest and throat started to swell. Doctor determined it was a delayed analphylactic reaction to the COVID vaccine. It was delayed due to taking the Allegra the previous day. He treated me with a benedryl shot and famotidine and prednisone in pill form. Observed for 1 hour and allowed to go home. As of April 5, 2021, still experiencing tightness in chest. Swelling in face has reduced

blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.

chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any activity; breathing was difficult; difficult for his wife to talk and walk (because of her breathing).; difficult for his wife to talk and walk (because of her breathing).; allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband) A 44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), intramuscular, administered in Arm Left on 21Apr2021 at 13:30 (at the age of 44 years old)(Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes Dose 1 on 23Mar2021 administered left arm, Lot Number: ER8727 and Expiration Date: 01Jul2021 for covid-19 immunisation ('had no problem'). The patient medical history was not reported. Concomitant medication(s) included phenylephrine hcl (PHENYLEPHRINE HCL) CVS brand NDC Number: 59779-094-68, Lot Number: 0EE3081 Expiry: Jan2022, taken for nasal decongestion therapy from Apr2021 and ongoing.No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. On 22Apr2021, The patient experienced chest heaviness/very strong heaviness in her chest, restricted breathing, allergic reaction, difficult for his wife to talk and walk, more breathless with any activity, breathing was difficult. The patient underwent lab tests and procedures which included electrocardiogram normal: results normal on 24Apr2021. Therapeutic measures were taken as a result of chest heaviness/very strong heaviness in her chest, restricted breathing. The clinical course was reported as follows Husband Reported on behalf of his wife got her first COVID-19 Vaccine dose 1, and had no problem, and was fine. He said when his wife got her second COVID-19 Vaccine dose on Tuesday, 21Apr2021, the first day she was fine, but towards the second day (22Apr2021), she had a very strong heaviness in her chest, and her breathing was restricted. His wife thought she may be having a severe allergic reaction to the COVID-19 Vaccine. Reporter made a few calls to the doctor, and the doctor told him to continue to monitor his wife, and maybe in a day, or 2, her symptoms would go away. On Saturday, 24Apr2021, his wife still had the chest heaviness, and it was very difficult for his wife to talk and walk (because of her breathing). On Saturday, 24Apr2021, the patient went to an urgent care. The doctor (clarified as a PA-physician assistant) looked for other symptoms his wife might have, and told his wife she did not have the COVID-19 Virus. He said his wife was told there were reports that the Pfizer COVID-19 vaccine was known for thickening the blood and for causing inflammation of the heart, said that she had an allergic reaction so an EKG was done at the time, and the EKG was normal. The PA (physician assistant) prescribed Ibuprofen 600mg (Lot Number: DE2607, Expiration Date Feb2022) by mouth daily. Also reported as (' 3 Ibuprofen 200mg tablets a day (600mg total),', and told his wife to return in 3 days if her symptoms were not better. It was also Reported his wife's chest heaviness had gone away, but the came back. Chest heaviness was not worse, but it had not gone away. The caller stated the doctor (PA) concluded that the Pfizer COVID-19 Vaccine produced too many antibodies in his wife, and the antibodies made his wife's blood thick. He said the doctor (PA) prescribed the Ibuprofen to help with his wife's blood flow. Subsequently the patient's husband had called Pfizer to report his wife's experience, but to also to find out how long his wife needed to continue taking the Ibuprofen. Reporter's wife, entered the call. She said the doctor (PA) suggested the Ibuprofen for inflammation. She stated she was more breathless with any activity (if she spoke or moved around). She said if she sat still, her breathing was fine. She said she was not physically tired at all, but her breathing was difficult. She said her chest heaviness was OK yesterday (25Apr2021), but when she woke up this morning, she had the chest heaviness again. She said her chest heaviness was better, but persisting. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected

blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021, Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out. Her tongue also began to swell. She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive. The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).

Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.

High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is a spontaneous report from a contactable pharmacist (patient) reported for herself that a 45-years-old female patient received first dose of BNT162B2 (lot number: EH9899), via intramuscular in left arm on 22Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant. No known allergies. No allergies to medications, food, or other products. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. There were no medical history or concomitant medications. The patient experienced high blood pressure 187/95, heart rate at one time 210 bpm, shortness of breath and chest pain on 23Dec2020 10:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for heart rate at one time 210 bpm which included lab works and medication given propranolol to decrease heart rate. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events hypertension, heart rate increased, chest pain and dyspnoea cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON.

felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue; arms and legs feel heavy; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek5730, expiration date: unknown), via an unspecified route of administration on the left arm on 30Dec2020 at 08:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included Hashimotos, Celiac, nonalcoholic fatty liver, and known allergies to gluten, eggs whites and eggs yolks, mustard seed, and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid (NATURE THROID), and an unspecified women's multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 08:15, also reported as within 10 minutes, the patient felt flushed and at 20 minutes, she started to itch and felt tightness in her throat. The patient left after 30 minutes to go home and take diphenhydramine (BENADRYL). The patient worked at night and slept most of the day except to take BENADRYL and call out from work. Also on 30Dec2020, she noticed fatigue when she woke in the afternoon and her arms and legs felt heavy. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of itch and felt tightness in her throat. She had been on BENADRYL 50 mg every 4-6 hours. The itching and throat tightness remained unchanged. She had used an albuterol inhaler 3 times. The patient did not receive treatment for the other events. The patient was not recovered from the events "felt flushed, itch and felt tightness in her throat, fatigue, and arms and legs feel heavy."

typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.

Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/7/2021   Date: 1/7/2021   Subjective Patient is a 45 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. Pt took allegra this am for allergies.   ALLERGY REVIEW OF SYSTEMS: All other systems negative     Previous Reactions: She states with first shot a few hours after her shot she had a rash on her mid back. and and lower extremities. Pt also had a head ache. Symptoms lasted 5 days.     Objective   Vitals Vitals:   01/07/21 1248 01/07/21 1303 01/07/21 1321 01/07/21 1334 BP: (!) 150/87 130/71 137/87 123/73 Pulse: 94 86 75 76 SpO2: 97% 99% 98% 99%         Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: Rash (on chest) present. Rash is macular. Comments: Flushing over the cheeks and bridge of the nose. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: antihistamines. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.Pt told if symptoms worsen or changed she is to be seen in the ER.   Diphenhydramine 25 mg oral given at 12:55pm.   Pt okay to go home with dad driving at 14:22 pm.     Electronically Signed 1/7/2021 2:03 PM      

After 15 minutes patient reported chest pressure which increased with inspiration. could not report rating on pain scale. Initial BP with complaints was 168/138. HR 88, RR 16, 98 o2sat, Temp 98.8. Follow BP 137/85 5 minutes later .Sent to ED at 12:53. 12 lead EKG, Normal sinus rhythm, no ischemia. CXR negative. Shortly upon arrival in ED chest pressure resolved with out further intervention. Pt discharged to home.

on day of injection approx 13 mins after injection RN was called to her car. She reported throat tightness, and dizziness 911 was called and pt was monitored until symptoms improved. Was not transported to ED. 2 days later developed a hive like rash and was seen at walk in clinic was treated with prednisone.

Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.

45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering, sweaty, and racing heart beats. Similar feelings with the first dose but much more mild. HR reports up to 120s. Check BP 144/109 HR 110 RR 18 --- > BP 135/91, HR 99-100 on discharge at 12:20 pm. Patient rests comfortably and feels a lot better. She has no respiratory complain or cardiac complain on discharge. Walks away without apparent distress. Symptoms resolved

The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours after injection I had chills, anxiety, slight shortness of breath, headaches, body aches. Today I have had nausea that comes and goes, the red knot is still present on my right arm and the redness has increased a small amount from the marking placed last night. The injection is not in my deltoid muscle or even close and I am wondering if that is at the least what created the redness and the knot.

after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrine injection and 911. patient waited around for about an hour after vaccination - patient BP went up, felt weak, signs of weakness, tongue big and throat closing - patient refused epinephrine again, called on call doctor who suggested Benadryl 25mg. Facility gave patient 25mg Benadryl IM. Patient to be monitored at facility

Pt reported chest tightness and throat tightness following vaccination. Time course following vaccination unknown.

shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling

After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.

During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 on an unknown date at a single dose for covid-19 immunization. On an unknown date, during her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. The he denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received antihistamines as treatment for the event until stable to go home and follow up with. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.

wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested

Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn't been great

Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later

4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen and Aspirin helped somewhat. 9pm severe fatigue, followed by worsened fever, worsened headache, throat tightness, nausea, myalgia, and waking hourly until 8am. Oral temp at 9am (1/17) was 100.6. Acetaminophen plus aspirin helped. 1/17 all day headache, malaise, poor appetite, and crying. 1/18 woke every 3rd hour to change clothes from night sweats. By 9 am had abdominal cramps, low grade headache, still malaise, and still low appetite. Still not recovered fully.

Was feeling anxious right after vaccine given. Laid in cot for a short time, then stated her throat felt like it was closing.

24 hours after the vaccine administration, patient began experiencing respiratory (asthma) symptoms. She was treated with nubulizer treatment and albuterol HFA inhaler.

12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion with cough. HD tested for Covid 19 (negative on 1/1/21) Started aka seltzer cold and flu medicine, seen in respiratory clinic on 12/31 - started new meds codeine with guaifanesin cough syrup, Flovent inhaler, and Mucinex Max strength cold and flu. 1/8/21, felt more fatigued and cough felt more violent. Seen again in respiratory clinic 1/11/21 negative chest X-ray and Covid 19 test, continue same regimen - rest, OTC, inhalers. 1/20/21, first day of feeling overall improvement, still ongoing cough.

3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.

Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.

High temperature starting at 3:00 am (101.84, 38.8 Celsius), severe headache, pain all over the body and shortness of breath, as soon as I tried to drink water I threw up, extreme tiredness and weakness. Slept basically the whole Sunday (1/17). Around late afternoon it started getting better and I was able to eat some soup. But still tiredness and weakness and shortness of breath. I took Ibuprofen 600 3 times that day but it didn't help. On Monday 1/18 headache got better but still extreme shortness of breath and weakness and back pain. Today 1/21 I'm still having shortness of breath and back pain.

Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication. The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

My right arm broke out in hives a few hours following the injection, and then my left arm a few hours later. The next morning my right ear swelled , was red and covered in hives and very painful. It continued to swell over next few days, very painful. I was feeling drained and had gastrointestinal symptoms for days and this morning woke up with my face swollen and another rash and hives on my face. I had a little trouble breathing as well and went to an Urgent Care. The doctor believes I had an allergic reaction to the vaccine and administered a steroid injection and prescribed steroids and antihistamines.

Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eyes, face and neck swollen- felt like her throat was swelling

Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she lost her voice and she had face and neck/throat swelling

I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.

joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021. All the events were reported as being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020. Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX). The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered. The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.

Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.

DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.

Second COVID-19 vaccine given 1/28/2021 at 4:00pm. Woke up next morning at 0500 with widespread intense itching and increased sinus congestions, hives develop about 11:00am with increased shortness of breath and wheezing. All signs and symptoms continued through today. Improve with increased Zyrtec dose to 2 - 10 mg, Benadryl 50 mg Q4, and Albuterol inhaler 2 puffs Q4-Q6. Improvement with medication regime.

Severe fatigue and headache lasting at least 2 weeks after vaccine. Symptoms still continuing. Had immediate chills, fever, sweats, etc consistent with vaccine response. However has severe ongoing fatigue, mild dyspnea on exertion, brain fog, etc causing inability to work.

On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine. After approximately 10-15 minutes I noticed a reaction. I was really lightheaded , short of breath, and shaking. It felt like I was going to pass out. I was given water and a bar to eat, and eventually I got to a place where I felt that I could drive. I went for a walk with a couple of friends, but was having a hard time walking because of shortness of breath, and was still lightheaded plus I had skin tingling on both sides of my face. I ate something afterward the walk and felt better within an hour. The next day I seemed to be fine, but then Friday (two days after the shot) I became increasingly lightheaded/dizzy and nauseous. Additionally, I had issues on Friday and Saturday with anxiety and trying to hold off mild panic attacks plus depression and nausea. I was still lightheaded/dizzy and had shortness of breath for a week after the shot. which has extend to today (February 5, 2021), over a week after the shot.

15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue, lips tingling and burning. After a couple hours my nose felt numb and tingly inside and stayed like that until the day after. The day after i had the vaccine if I try to eat it flairs the burning fizzing feeling in my mouth and lips again. Feel week and tired, headaches and body pain. Im concerned with the mouth stuff though before getting the second dose.

1640 Red palms, flushed, arms itch hx sensitive skin feels throat full. denies, dysphagia or dyspnea. Benadryl 25mg po. 1645 Vital signs 160/100,97%,76. 1655 D/C amb. without problems.

swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.

1/29/2021 at apx 5:00am patient stated to have an upset stomach. Later in the day at apx. 12:00pm patient stated to have a fever of 102.0 F and beginning of a rash throughout her body. Symptoms continued through the following day. 1/31/2021 at apx 5:00am patient stated to have swelling of her throat and went to the emergency room. Patient given IV and gastrointestinal cocktail. Patient sent home steroid and diphenhydramine prescription.

fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm left on 04Jan2021 08:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included asthma, obesity. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), macrogol 3350 (MIRALAX), montelukast sodium (SINGULAIR). The patient previously took cefalexin (KEFLEX) and experienced Known allergies: Keflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 01:30 PM Intramuscular in right arm for COVID-19 immunization. The patient experienced fever, chills, weakness, rash all over the body, sob all on 04Jan2021 12:00 with outcome of recovered in Jan2021. No treatment was received. Information on the Batch/Lot number has been requested.

5:50p - during standby period I began to feel itching on my cheeks, scratchy throat and then my nose began getting congested. 6pm - my nose was completely congested and my entire face, throat and neck was itching. 6:10p - my eyes were itching and the itching continued across my entire chest and down my entire left arm. 6:15p - upon finding nurse that administered shot advised of having reaction. Eyelids were swelling by this time, shortness of breath and vision blurring. 6:35p -While nurse was assessing my vitals code called and ER team arrived to conference room. Upon assessment by ER team, symptoms escalated with reddening of mouth and throat and multiple extremely high BP readings(highest 181/101)

Heart palpitations, cold/numb face half hour after vaccination. Sore arm 2/5/21. Woke up feeling like I slept wrong and pulled muscles in my back 2/8/21. Shortness of breath, sore back and chest, left side, hard time getting comfortable going to sleep, 2/9/21. Condition spread to left chest during the day, wondered if I was having a silent heart attack, very difficult time getting to sleep, felt like I had a cracked ribs, back left, 2/10/21. Pain grows to include right side of chest and back, lungs feel like they can't get filled deeply without pain, sleeping pain shifts to right side, 2/11/21. Yearly gyno appt, Dr said lungs and heart sound good, likely side effects of vaccine. Cracked ribs sensation moves to right side of back, difficulty getting comfortable, woke up several times from discomfort, 2/11/21. Shortness of breath and pain breathing during the day, 2/12/21

Patient came in and got her first dose of the Pfizer COVID vaccine at 1515. Patient stated she had no allergies and no issues with vaccines in the past. Patient received the vaccine in the right deltoid, IM. Patient tolerated procedure well. Patient walked to main lobby to wait for her 15 min observation time by a staff member. Approximately 5 minutes after receiving the vaccine the patient approached the staff member observing patients that are in their observation window and stated ?something doesn?t feel right?. At this time the staff member called for a nurse to the lobby. When I got to the lobby and asked the patient what was going on she stated ?that she feels weird in her entire body?. I asked the patient if she was able to walk and took her back to the clinic to an exam room. Once in the exam room the patient stated that she ?just feels weird and that her heart is racing?. The patient started to get red blotchy spots on her shoulders. The patient stated that she was having no trouble breathing and did not feel like her throat or tongue was swelling. The patient?s blood pressure was 190/100, HR 89 and oxygen saturation was 98%. I gave the patient 50 mg of Benadryl PO. Patient stated she was only allergic to erythromycin and takes sertraline and vitamins as her only medications. I had the patient lay down as she felt a little dizzy. The patient was breathing heavily but was not having any trouble with SOB at this time, she called her husband to come join her. The patient continued to feel the same symptoms but they were not worsening. Approximately 5 minutes later her blood pressure had decreased to 170/94. The patient stated that she was feeling the same. 20 minutes after the patient took the Benadryl her red blotchy spots had decreased and she was starting ?to feel better overall?. The patients husband stated that he would watch her tonight and continue to monitor for symptoms. I recommended that she go in and be evaluated if her symptoms persist. The patients blood pressure 30 minutes after taking Benadryl was 140/94, pulse 73, oxygen 97%. The patient left with her husband with the understanding that if her symptoms get worse or persist to go in and be seen.

injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.

shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling, difficulty swallowing and speaking, nausea, numbness of lips

Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.

First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for "First dose administration on 19Dec2020 and second dose administration on 12Jan2021" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She does report a sensation of feeling like difficulty breathing or swallowing and is initially treated with Solu-Medrol and Benadryl as well as IV fluids. She reports that symptoms are improving almost immediately after meds are pushed. As result epinephrine is initially deferred for continued monitoring. However upon reassessment approximately 1 hour after reported reaction, the numbness in the hands and feet have resolved, but she is complaining that she feels as though the back of her tongue is swollen and still making it difficult to swallow though she no longer feels short of breath. As a result, we have discussed the possibility of treatment with epinephrine in order to fully resolve symptoms, and she is agreeable to proceed. ,

I had a sore arm and a slight headache the day after the Pfizer injection. I went out to the grocery and had a total panic attack. I had to leave the store. It took amazing effort to do this. I then had to sit in my car for an hour and talk to a friend to de-escilate enough to drive home. I have spent the entire week very close to my bed. Even getting up and taking a shower causes me to panic- heart rate increase, shallow breathing, cold sweat, the feeling that I am coming out of my body or will pass out. All I have been doing is laying around for one week?s time. I have anxiety but nothing like this. I do not know if I should take the second injection. I am fearful that this will be so much worse after taking the second injection. I did call my PCP and the nurse did a phone review with me telling me that I should take the second injection and that anxiety / panic attacks are not a known side affect of this injection.

While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chewable (12.5mg each) benadryl tablets. after about 5 min. i felt stable enough to leave. on the way home I started to feel the itching intensify and I felt very warm. I had welts forming and hives appeared all over. As I pulled into my driveway( 7 min drive from vaccination site) I felt my lips and eyelids swell, and my throat felt tingly. I took another 2 chewable benadryls. (12.5mg each). I immediately called my Doctor and explained what was going on. I also started to wheeze. I used my inhaler. He told me to use my epipen. Which I already had prepared since I knew this was anaphylaxis. I started to feel stable enough to go inside. I called my husband to come downstairs to be with me. I still wasnt feeling well and the tightness and wheezing persisted. At around 8:40, My dr. told me to use the 2nd Epipen and use my nebulaizer. If I wasn't better in 10 minutes he would call an ambulance. Thank GD the itching and hives subsided and the wheezing and tightness diminished by aroung 8:50am. My dr. comtinued to monitor me and check up on me. By 3pm I was back to myself.

1.5 hour post-vaccine throat swelling. Seen at anther hospital, tryptase drawn >2 hours after vaccine - results unavailable. Has not confirmed anything else after that.

PT called the location at 15:45 stating that she had a reaction at 8:00 am which included wheezing and feeling like throat was closing. She took her own Benadryl and utilized her own epi pen on the advice of her own physician. The symptoms subsided when she called.

dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

The patient presents with symptoms that started immediately after pt received her first covid vaccine around 1000 today at center. she developed lightheadedness, sob, nausea, h/a, and when er triage nurse was triaging her she syncopized for 3-4 seconds. no fall. pt was seated. and pt also reports that earlier she felt like the room was spinning. Tx in the ED w zofran and discharged.

Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear her throat. She had mild flushing as well. The hoarseness was on and off for a few minutes. Pulse ox was 97-98% on room air and was given PO Pepcid 40mg and PO Benadryl 50mg while in vaccine clinic. She was transported to the ED (chief complaint recorded as "hoarseness, chest tightness, SOB, throat swelling") where she was given IV Pepcid 20mg, IV Benadryl 50mg and IV SoluMedrol 125mg. She remained on room air and vital signs remained within normal limits. The patient was monitored for 2h before discharged home. Patient was given an outpatient prescription for Medrol DosePak and Pepcid.

Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction didn't go away until 2 hours afterwards. Puffy, itchy eyes (both eyes) with rash came and lasted about two weeks. Monday or Tuesday, I noticed a rash all over my body - red and blotchy. That went away in a day. I got chills, fever, weakness, nausea, vomiting, diarrhea and that lasted 48 hours (16th in pm-17th and got better evening of 18th). When I had the rash was all over the body, I took a Zyrtec. The weekend I was really sick I didn't take any medication. Phone visit with Doctor - January 15th - allergist - I followed up with him about the throat constriction. He just was monitoring symptoms. After the weekend that I was really sick, I told him and he ordered bloodwork.

Asthma flair - 6 hr till 36 hrs after shot. Fever 101.1 24 hrs after vaccine Body Aches Site of injection Red, welt, hot Itchy. Took Asthma medication,, Tylenol

Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.

short of breath to the point that I had to go to the ER, symptoms lasted for about 10 days and I still not feeling 100%, dizziness, unable to function for 10 days, only laying down make me feel better

Report couldn't breath, couldn't stand up or walk. Stated started to black out, fever 102.0, chills and nausea. Treatment: nothing Outcome: Continue to be short of breath with walking, body aches improved. Advise to see her PCP or seek urgent or emergent care if become SOB.

Immediately after receiving the vaccine at 1156, patient felt swelling in throat. The symptoms resolved a few minutes after, however they returned. She was given 25mg of Benadryl around 1201. About 1230, patient took another 25mg of Benadryl. She said the swelling was better, but she was not at baseline. We continued to observe her until 1320. At that time, she felt that throat was normal. She was drinking water, walked to the restroom, and stated she felt better. We had her contact her sister who lives 2 doors down.

chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Called to the vaccination floor to assist a patient who was noted to be retching. The patient had just received the 2nd dose of the vaccine and reported soon after the administration she felt as if she had trouble breathing and without saying or waiting she injected herself with an epi-pen she carries. She reports a H/O POTS, Gaucher's and Mast Cell activation and that at her prior dose had mild symptoms but later revealed after 2 days of getting her first dose she had to inject herself due to respiratory difficulty. The patient decline EMS intervention and transport. She was observed in the POD > 30 mins , over which time her symptoms resolved completely and it was safe to send her home. Her husband will drive her home. It was recommended that she follow up with her PCP and allergist ASAP.

experienced headache, severe dizziness and Shortness of breath. Accompanied via Security officer and vehicle to the ED

On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine. In the evening around 11 pm, I experienced difficulty in breathing and had a slow heart rate. In addition to muscle pain on my left arm where I got the shot, whenever I almost felt into sleep I was startled and woke up from short of breath. I wore a watch to check on my heart rate. On the low end it went into 53 ~ 54 especially when I felt short of breath. On the high end it was around 67 ~ 70 which is my normal heat beat when at rest.

Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vaccine on 3/13 at 4:30pm. Immediately afterward she had sensation of lip and tongue swelling. She was given Zyrtec and monitored by the vaccination clinic for 30 minutes. She was discharged from the clinic after improvement of systems. Lip swelling presented on 3/14 at 2:00pm and she took Zyrtec. At 10pm, patient felt sensation of swelling in throat and presented to ED. EMS gave patient 50 mg IV Benadryl. Patient discharged on prednisone. Patient re-presented to ED on 3/16. Allergic symptoms subsided, but patient complained of atypical chest pain with paliptations, tremulousness. Suspect adverse reaction prednisone. She was given cardiology referral for follow up if her symptoms persisted. She remained in normal sinus rhythm with initial sinus tachycardia. Was discharged home in stable condition and counseled to return to ED for any concerns.

Approximatey 1hr after the vaccination, c/o of feeling internal itching all over but under the skin at 4:30. An hr later c/o "flu like symptoms e.g. aches and pains, then had to take a nap. Woke up the next morning c/o soarness, itching, and self-administred Zyrtec 1 po in a.m then again in the p.m. Felt some relief but a little achey just flu-like. Most of Sunday felt the same but Sunday approx 6p broken out into red whelts on the chest and back, throat felt like it was starting to close in and I went to the ER at approximately 8 p.m. Was given Prednasone 10 day pack, and Benadryl both p.o. Did receive somewhat relief from the Rx. Nothing was done to airway. Continues to c/o itching underneath the skin

Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. Less than 24 hours I was in severe pain. Felt like my bones hurt. Swelling on the left side included my armpit and left side of the torso down to the waist. The pain stayed for another day. Felt like I had the flu. Swelling in the armpit and upper left torse stayed for about three weeks. Wednesday, March 17 I went to the ER for chest pains, throat tightening, pain from my shoulder to my hand on the left side.

1605-Pt c/o fast heart rate. Interpreter immediately with pt and nurse to translate. Husband brought to pt. BP-142/90 with heart rate 132. Chest and face flush. Received 25 mg benadryl po. Pt stated she was feeling better. 1610-BP-124/82 with heart rate 117. 1615-Pt started c/o of heart racing again. Heart rate 130 and pt now c/o sob and headache. BP-140/84.

Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injection till 14 days after injection, sometimes subsiding with Benadryl), Feeling of right side of throat closing in (20 hours after injection, but improved with Benadryl), Red spots on upper lip together with swelling (1 day after injection till 11 days after injection, at times disappearing with Benadryl), Both lips swelling (1 to 2 weeks after injection, on and off), Headaches (most days from 2 days after injection till now, 16 days after injection), Stiffening of the back of the tongue (20 hours after injection, cured with Benadryl), Nausea (2 days after injection, every few days till 16 days after injection), Low fever (5 times, every 3 days since 3 days after injection, till 15 days after injection), Diarrhea (around every 5 days since 4 days injection), Joint pain (from 2 days after injection, continued around 6 days), Nerve pain (continuing two weeks since a few days after injection), Chills (on and off, from around 3 days after injection till 1 week after injection), Fatigue (going on 16 days since an hour after injection).

Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65. My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.

I had leg weakness, feeling like both legs going to give out about 15 minutes after vaccine, later feeling of fatigue and unwellness. Couple of days later had dysphagia, food getting stuck in throat, throat tightness, feeling of phlegm, severe leg spasms in both legs, I could see spasms/jerking through pants, then had arm and hand tremors/spasms and leg weakness/feeling of legs going to give out. I had to go to ER and then had relapse of same symptoms week later. I still have dysphagia, unable to swallow solids, food and pills stuck in throat, throat tightness, weight loss of 12lbs, leg weakness and pain, excessive fatigue.

1335 Contact made with pt in observation as she came into the area. pt stated she was having itching on her face and neck, also having an asthma attack. She was coughing, audible wheezing. Took 4 puffs from her own Proair inhaler and took 2- 25 mg Benedryl tab that she had with her. 1340 EMT at car. Pulse Ox 93% HR 107 they placed a O2 mask.1400 Alberturol Tx given by EMT and 50 mg Benedryl IM given. 1425 Pt feeling better and asked to be released. Released by EMT with ER warnings. Pt denied to administering nurse that she had a previous reaction with the Pfizer vaccine.

Pfizer-BioNTech COVID-19 Vaccine EUA around 2:30 am began having chills, and muscular aches both of which continued for approximately 18 hours. around 7:30 am began also having headaches which persisted for about 12 hours. Also had fatigue, possible due to not sleeping well due to sx. Around 10:00 am began having difficulty concentrating, headaches, muscle aches and chills intensified. Around 11am confirmed fever of 100 d F, took Tylenol which lessened chills. General malaise continued through evening, 8pm, took another Tylenol, by 9 pm began having series of intense and persistent (nonstop) heart related symptoms (chest pounding, tachycardia, shortness of breath,) which continued for several hours. (exact time unknown, I am guessing it lessened around 2am or so.) Following am, all symptoms gone. (might have continued to have some intermittent heart stuff as that has been ongoing every day, but non-stop intense cardiac feelings were not continuing by morning.

5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.

15 min. after administration, pt became short of breath and hoarse. Hospital Rapid Response called, pt took Benadryl 50mg PO and then transported immediately to the ED for further evaluation. ED administered Solumedrol and epinephrine.

tachypnea and tickle in throat with first dose of Pfizer mRNA COVID-19 vaccine IM in right deltoid. Taken to ED. Gave diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV. Symptoms resolved and patient discharged in stable condition.

Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and chest.; Instant hot fire feeling in stomach and chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Information on the Lot/Batch number has been requested.

I started with a cough and that got progressively worse until I started throwing up. After throwing up I felt like I could not get enough air for about 40 mins. I had a Abuteral inhaler left from fighting bronchitis so I took a few puffs of that and started to feel a little better. Through the night I continued to throw up a few times and having a lot of coughing. The next day mt throat was on fire and could not really talk. I am assuming this was from all the coughing and throwing up.

5 minutes post administration: Throat tightness, facial tightness, itching to throat, chest, and upper extremities. Treated in ER: EPINEPHrine 1mg/mL injection 0.3mg IM, diphenhydramine 50mg IV, Solu-Medrol 125mg IV, d/c to home with Rx for prednisone 50mg 1 tablet by mouth daily x5 days. Pt kept in observation for 4 hours post Epinephrine/diphenhydramine/solumedrol with marked improvement. D/c to home for continued care with PCP in community.

congestion; Fever; headache; weakness; arm pain; armpit pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN5918) via an unspecified route of administration in the Left arm (at the age of 45-year-old) On 18Feb2021 at 10:45 as a single dose for COVID-19 immunisation. The patient medical history included Hypoglycaemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included buspirone hydrochloride (BUSPAR), (sertraline hydrochloride) ZOLOFT, simvastatin (ZOCOR), amitriptyline, clonazepam (KLONOPIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Flonase and experienced allergies and also took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 28Jan2021 at 13:45 in the left arm (at the age of 45-year-old) for COVID-19 immunisation. On 18Feb2021, at 17:00 the patient experienced Fever, headache, weakness, congestion, arm pain, armpit pain. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Information about Lot/batch has been requested.

I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain, shortness of breath, sweating and chills. I went to the ER, and they discovered two blood clots in my lungs. I've never had pulmonary embolisms before, so this is a very strange coincidence. I am in cancer treatment, so my risk of PEs is higher, but the timing is too close for me not to think that the second vaccine traumatized my immune system, causing the PEs.

acute right flank pain and difficulty breathing a few minutes after vaccine. Onset was quick and within 5 minutes of initial flank pain, I was unable to take a full breath in. It felt as if someone was stabbing my right flank - bra level - and taking a breath in was very difficult. minor relief was experienced when leaning forward and applying tension (I was leaning forward and pressing my arms against the seat of the chair to apply tension to the area. I was unable to sit straight, stand, walk or move very well without acute stabbing pain in my flank. I was transported by ambulance to the emergency room where I was told that I has a minor UTI and had "pulled a muscle." This "alleged" pulled muscle happen while I was sitting perfectly still in a waiting area on a conference. As a note, I am not nervous of injections or of the vaccine. I was feeling great before, during and immediately after the injection until the pain began. At onset, I felt an intense heat at the injection site that radiated throughout my upper arm around the injection site followed by uncomfortable flank pain and shortness of breath. Within minutes, the flank pain became acute and it was difficult to catch a full breath without pain - likely due to the acute flank pain. I was released from the emergency room at approximately 3:00pm with a prescription for antibiotics for the UTI and muscle relaxers..

20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat started to swell. This is a typical mast cell reaction for me. I took 20 mg of Fomatadine a few minutes later. I had already had 50mg Bendryl on board. About 20 minutes after the Fomatadine the swelling in the throat started to improve slightly. I left the facility where I had the shot after about an hour and my condition did not worsen. I fulle recovered in about 48 hours.

Day1- Cold sensation, felt tight throat when trying to swallow liquids; day 2- went to er at Regional Medical Center for chest pain, sob; went to PCP, reports that she has been having cold arms and leg (raynaud's like presentation) went to Hospital er twice, now is in Regional Medical Center er with chest pain, headache, generalized weakness, reports that the cold sensations continue, patient was started on hctz after the vaccine for high BP, then amlodipine, patient was then taken off amlodipine and hctz and started on bystolic; tight senstions in the throat continue along with cold sensations; intermittent chest pains, headache

In the evening - I had a mild headache and chills; And had generalized joint pain and soreness on the arm on Saturday and Sunday. Those all continued for a few days and then that resolved. Shortness of breath and chest pain started 10 days after - they lasted for about a week and they resolved simultaneously. I went to my doctor and he did some tests. Everything was normal. No treatment except diet and exercise.

Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and rescue inhaler

Client stated they were experiencing some tightness in the throat with some numbness and tingling; no difficulty breathing. Ambulance was called and Client was transported to nearest facility

Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.

Have been feeling completely fine. Not been sick at all. About 5 hours after shot my throat started to feel scratchy and dry. Next morning feels all day like I have pharyngitis. Also tired. My lungs/chest hurts.

Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. Swollen lymph nodes in armpits and under jaw. Bed rest, sleep, daytime/nighttime cold medicine, liquids.

Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty breathing. patient was transported the EC. Blood test, urine test, CT chest w/o contrast. Was told pulled a muscle while sitting and doing nothing (@ holding area). Correlation can't be made with any degree of certainty if related to vaccine. Felt burning sensation in arm after receiving vaccine and then pain on right side right under armpit (stabbing sensation). Every time took a breath in, felt pain. Patient reported having a hard time walking. Wasn't given any medication in EC. Pain was manageable after 5 hours.

Severe allergic reaction - Hives, Itching, Burning, loss of breath, fainting I was unable to sit or stand. So my husband called ambulance and they took me to emergency room

is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis

Patient received Pfizer first dose on 3/22. Over the course of the next few days, patient experienced hives and throat closure. She had to be hospitalized in ED on Friday 3/26

Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

This is a spontaneous report from a contactable consumer reporting for self. A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation. Medical history included asthma and allergies. The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever." The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.

Severe allergic reaction; Fainting; Hives; Itching; Burning; Shortage of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 08:45 as single dose for COVID-19 immunization in an hospital. Medical history included known allergy from an unknown date. There were no concomitant medications. No other vaccines taken in four weeks. No COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. On 10Apr2021 13:00, the patient experienced severe allergic reaction - hives, itching, burning, shortage of breath, fainting. She was unable to stand or sit, and had to call ambulance and go to emergency. The events resulted in emergency and physician's office visit and required hospitalization. The patient was given a steroid and unspecified allergy medications as treatment. The outcome of the events was reported as recovered. Information on the lot/batch number has been requested.

Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.

Pericarditis; Woke up with chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on an unspecified date 02:00 PM in Apr2021 (Lot Number: EWO158) as single dose for COVID-19 immunization. Medical history included Interstitial cystitis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No and other medications the patient received within 2 weeks of vaccination. The patient experienced pericarditis (hospitalization) on 13Apr2021 00:30, woke up with chest pain (hospitalization) on 13Apr2021 00:30, difficulty breathing (hospitalization) on 13Apr2021 00:30. Patient was hospitalized from 13Apr2021 to 14Apr2021. Clinical course: Woke up with chest pain and difficulty breathing one week after first dose. Went to the hospital and was diagnosed with pericarditis. The adverse event resulted in Emergency room/department or urgent care. Treatment received for the adverse events which included anti-inflammatories and colchicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, Nasal Swab Negative on 13Apr2021. Outcome of the events was recovering.

Patient presented to Community Center at her scheduled appointment time to receive her 2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported she experienced a feeling which she describes as a "a shot of adrenaline" about 5 minutes after administration of first Pfizer COVID vaccine. RN responded. Client symptoms of elevated heart rate, shortness of breath and dizziness lasted 1-2 minutes and resolved without treatment. Client did not follow up with PCP.

Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck  

Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/18/20. Went to ED on 12/20/20. Not reported as serious adverse effect, but medical record labeled with moderate reaction. Diagnosis: vasovagal episode. Discharged stable.

Patient states she was advised by nurse that because it was intermuscular (triceps), it may be because she is experiencing a headache that lasted 36 hours, also fatigue for 5 days, also joint stiffness for 7 days and she states she felt very sore and stiff and had a hard time walking up and down stairs without feeling shortness of breath. Said she felt "run down". On day 8 (12/31) she felt a lump like a mosquito bite. Day 9 the injection site became red and became very hot to touch. No fever reported. She was advised to see a nurse and was advised it could be hypersensitivity and to report this. This happened on 01/02/2021

Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)

Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.

rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.

Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.

12/23: developed soreness 12/30: developed runny nose, congestion, cough 12/31: fever 100 deg F and chills

Patient while waiting after receiving her second COVID Vaccine dose started to feel short of breath, anxious and shaky. She was taken to the ED, where they took a set of vitals, listened to her lungs (clear) and completed an EKG.

Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.

Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe

About two minutes after vaccination the patient began to experience itchiness and throat tightening. Was administered 50 mg capsules Benadryl PO and continued to have worsening symptoms. A physician on site ordered her sent to the Emergency Department for further treatment and observation. She was given famotidine and prednisone and had significant improvement of her symptoms. She was discharged to home

Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feeling jittery and shaky. Oxygen saturation remained normal. Vital signs normal.

difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in her mouth; This is a spontaneous report from a contactable consumer (spouse). A 46-year-old female patient (wife) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number: EH9899) via unspecified route of administration at arm right on 29Dec2020 at single dose for Covid-19 vaccine. Medical history included ongoing anxiety diagnosed 22 years ago. Concomitant medications were not none. Patient received the vaccine and was one big hive (01Jan2021). She went to the ER on sat and will have to go back. Caller is asking where she should go. patient went through the VAERS report 3 times. She did not have any sides effects. patient is a frontline worker. On 29Dec2020 she got the Covid vaccine. On Sat 02Jan2021 she went the ER with hives all over including in her mouth, stated she had difficulty breathing/swallowing, was given medication to take home and discharged. She was readmitted yesterday 05Jan2020 with worsening symptoms and needed to be given a prednisone nebulizer. they had two ER visits. No Investigation Assessment. patient was not recovered from the event hives/hives all over including in her mouth, the final outcome of other events was unknown.

she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.

15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .

Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.

1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache, fatigue. Took tylenol and slept. Next morning, 1/10/21,w oke up at 10am, fever 102, continued with chills, sweats, body aches, joint pain, headache, fatigue and began with intermittent SOB. Took tylenol and slept most of the day and night. Next day, 1/11/21, temp 100.8, continued with chills, sweats, body aches, joint pain, headache, fatigue, intermittent SOB and chest pain. Continued to take tylenol and alternated with ibuprofen. Rested most of the day in bed. 1/12/21, no fever, intermittent SOB with activity, continue with headache and joint pain. 1/13/21 better today. Continue with intermittent SOB with activity and feel fatigue. No fever.

Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I better about 20 minutes latter. I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.

throat is swelled; hard for me to swallow; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the Pfizer vaccine for the COVID-19 on 29Dec2020. She reported that it was hard for her to swallow on an unspecified date. It was not when she was eating or drinking, just sitting down. She was having trouble swallowing on an unspecified date. It felt like something in her throat swelled. She was having trouble swallowing. She works as a lab assistant. As for the treatment, she said that she has a doctor appointment on Monday (unspecified date). She had been taking diphenhydramine hcl (BENADRYL) as treatment. The outcome of the events was unknown. Information about lot/batch number has been requested.

Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday around 1130am- went home from work and took ibuprofen. stayed home from work Wednesday- started to taper off pre immunization medication of benedryl, Pepcid, and prednisone on Wednesday afternoon. Wednesday night noticed using my inhaler. Little more- I took Half dose of prednisone. Had to do nebulizer treatment later that night. Thursday morning woke up wheezing took another prednisone and used rescue inhaler. Went to work and wheezing didn?t get any better, but didn?t get any worse. Took another prednisone and sent home to do nebulizer. Continued to rest and monitor asthma- Notified PCP of what was going on- advised to continue Pepcid, benedryl and prednisone for a few more days and advise of any issues.

severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; it took a minute for her to catch her breath; flushed; itchy; muscle aches; something that look like hives on the arm/hives on the lower right arm; skin felt really hot to touch; fire engine red on the right upper arm; pain at the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 06Jan2021 11:00 in deltoid left at single dose for covid-19 immunization. There were no medical history and concomitant medications. Family medical history relevant to event was none. Relevant tests were none. Patient reported she received the Pfizer COVID-19 vaccine on 06Jan2021 and had pain at the injection site. On 07Jan21 she started having muscle aches and got something that look like hives on the arm and her skin felt really hot to touch, it was fire engine red on the right upper arm. On 08Jan2021, she woke up and felt like she got hit by a tractor trailer, has severe aches, voice very raspy, and very wiped out with headaches. Patient mentioned injection site arm was bright red and warm to touch after injection, but has improved. When waking up this morning on 08Jan2021 even walking this morning from the bedroom to the bathroom she was fatigued and it has gotten better with her walking around, but she still felt wiped out. The muscle aches was very short lived. She went to do something at work and it took a minute for her to catch her breath and that and the muscle aches went away and that was it. An hour later she felt very flushed and itchy and coworkers joked with her about what she ate for lunch, which was nothing different. On the opposite arm from injection arm she had hives on the lower right arm. They were there about 15-20 minutes and it turned completely fire engine red and that lasted about half an hour. She showed the doctor she worked with and they recommended diphenhydramine hydrochloride (BENADRYL), which she didn't take, it was weird. All this subsided and she felt fine afterwards. Last night she felt very fatigued when walking around the house. This morning when she woke up she felt very, very, very fatigued. Walking took a lot of effort out of her. It is hard to explain, but people say this was how they felt when they had Covid. She felt very lethargic and very tired. Patient still had a lingering headache, but nothing like she felt earlier this morning. It's not terrible, but it wasn't pleasant for a couple of hours. Patient was unable to provide seriousness for today's events (08Jan2021), and stated it wasn't really life threatening, but more significant than yesterday. Patient denied having any other vaccines the same day or 4 weeks prior. No history of problems or adverse events with vaccines in past. Pfizer Covid-19 vaccine with events were reported as related. Events did not require a visit to emergency room or physician office. Outcome of severe aches, voice very raspy, headache/lingering headache, wiped out /fatigued/tired were not recovered; outcome of lethargic, it took a minute for her to catch her breath, flushed and itchy was unknown, and outcome of other events were recovering.

Low grade fever, muscle aches, fatigue, nausea, headache hours 17 - 29 post vaccine. Still continuing to have headache, as well as fatigue and shortness of breath with activity.

Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.

arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.

Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.

Sudden, intense pain in the mid sternum just to the left side. She recalls some dull vague pain over the past night, but the sudden pain developed about 3 minutes before I came into her office. Pain was a 10/10 in severity and made it difficult to breathe and talk. She was able to tolerate snow blowing this morning without notable difficulty. Pain is not clearly exertional in nature.

This time I predosed per allergersit recommendation with 25 mg benadryl, 300 mg pepcid, zyrtec 10 mg and acetominopehn 500 mg 2 hours prior to vaccine. 15 min in I got wheezing, thorat tightness and tongue numbness. EMTs again called and again sats ok, BP ok and HR in 90s. Wheezing better with 4 inhalations of Albuterol HFA. They wouldn't give me any meds without sending me to ER, so I left and went home and took 50 mg Benadryl and another 2 sprays of albuterol at 4 hours post vaccine and did well.

I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ALbuterol and monitored by EMTS for 30 mins more. I had sl elevated BP 148/86 and pulse ox at 97% and HR 95. Symptoms improved 20 min after Benadryl so I was released hom as I had my own epi pen and was a doctor so could self monitor.

Patient had received second Pfizer vaccination after no reported issues with the first dose. Patient was observed post vaccination without incident and released. Patient developed wheezing and attempted to treat with her albuterol inhaler but did not improve. patient presented to the ED approximately 2 hours after vaccination and was admitted for respiratory failure and placed on BiPAP for a brief period of time. patient has known history of Asthma Exacerbation requiring hospitalization and intubations. D/C diagnosis Asthma Exacerbation

1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS. Evaluated by PA - Code Green called. VS stable, transferred to ICU> In ICU labs completed, monitoring continued - all stable. Ate sandwich without difficulty or N/V. discharged to home 1/13: Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache. Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth. Called 911 - transferred to different hospital. Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP. 1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.

Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.

Employee experienced shortness of breath, chest tightness, nausea and headache after vaccination and needed prolonged monitoring post vaccination. Improved with rest.

Occasional chills; mild chest pain with deep breath; mild chest pain with deep breath; This is a spontaneous report from a contactable consumer (reporting for a patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 08Jan2021 12:00 at a single dose for COVID-19 immunization. There was no other medical history, had no known allergies. Concomitant medications were not reported. The patient did not have COVID and did not receive other vaccine in four weeks prior to vaccination; did not have other medication within two weeks and was not pregnant at the time of vaccination. On 08Jan2021, the patient experienced occasional chills and mild chest pain with deep breath. No treatment was given for the events. The patient has not been tested for COVID post-vaccination. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.

On 12/31/2020 patient received her 1st dose of Covid vaccine while she was on her 4th day of antibiotics to treat a UTI. On 1/6/2021, patient started to have a rash and experience difficulty breathing. Patient went to ER and her antibiotics was changed. Patient has not had a reaction to either antibiotics in the past. This may be a duplicate submission, but did not receive an email confirmation so I am resubmitting.

Patient received vaccine on 12/31/2020. Patient was on day 4 of antibiotics for UTI when she received the vaccine on 12/31/2020. On 1/6/2021, patient started to experience a rash and difficulty breathing and went to the ER. The ER started her on a new antibiotic. Both antibiotics that she received, she has been on before and has never had a reaction.

allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

On 1/17/2021 @ approximately 1130, I ran upstairs and began experiencing extreme shortness of breath, dizziness and increased heart rate with what felt like palpitations, as well as a massive headache. The symptoms resolved subsided after 10 minutes, but returned again shortly afterwards. After taking some Advil 200mg x 1, my symptoms improved but I still remained fatigued and had difficulty breathing at 100% the rest of the day. After the 2nd episode 911 was contacted and FD arrived at my home. All vital signs, pulse & O2 were WNL, except BP @ 153/99. I've had one previous experience with this and it was while taking Izoniazid as a TB prophylactic after a 6 month treatment. As of today, my symptoms have resolved and am back to my usual state.

PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of chest discomfort and breathlessness, and I went to the doctor. Their frequency/severity trended toward improving, but after the 2nd vaccine I was back to their original intensity/frequency. I do not have a history of similar. They are affecting my daily life. I've been referred to a Cardiologist.

Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort Joint discomfort

STABBING HEART PAIN FELT LIKE MY HEART STOPPED AND I GASPED FPR AIR AND HAD TO COUGH THIS HAPPEND WITHIN SECONDS 3-5 TIMES A NIGHT FOR 2 WEEKS

I have had muscle aches, joint pain, headaches, fatigue, feeling feverish, and having shortness of breath since the morning of 01/28/2021 until the present moment.

Acute asthma attack; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), intramuscular in the left arm on 15Jan2021 07:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced acute asthma attack on 15Jan2021 08:00. This adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of acute asthma attack and included treatment with albuterol inhaler. Outcome of the event was recovering.

Chest tightness, shortness of breath, throat tickle then tightening, coughing, rash.... monitor ( bp high, o2ok ekg looked like a fib then was ok) then epi, used inhaler, benadryl, epi and then taken to hospital where I received steroid injection and prilosec with continue monitoring. Next 5 days medrol pack, benadryl and prilosec

Pain in the injection area (left arm), headache, Congestion, breathing difficulty. Consulted with the Dr. and prescribed the usual asthma treatment (Albuterol every 4 hours) and Acetaminophen for the pain. The 1st dose of the vaccine was received.